Examples of Premarket Submissions that Include MMAs Cleared or Approved by the FDA
The following is a list of some of the mobile medical applications that the FDA has cleared or approved since 1997.
For more information about any of the apps below, please search either the FDA 510(k) medical devices database by 510(k) number or the PMA database by PMA number.
On September 27, 2019, the FDA issued final guidance Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act, which outlines the FDA's interpretation of the types of software that are no longer considered medical devices. As a result, some of the products listed on this page may no longer be considered medical devices.
FDA-Cleared Mobile Medical Applications
Last updated (July 25, 2018)
| Device Name | Applicant | 510(k) or PMA number | Clearance Date | Product Code | Product Code Description | Regulation | Regulation Description |
|---|---|---|---|---|---|---|---|
| ISage Rx (ISage Rx Basal Insulin Titration) | ISag Rx, Inc. | K161865 | 3/7/2017 | NDC | Calculator, Drug Dose | 868.1890 | Predictive pulmonary-function value calculator. |
| DEXCOM G4 PLATINUM CONTIUOUS GLUCOSE MONITORING SYSTEM, DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM | DEXCOM, INC. | P120005/S050 | 3/8/2017 | MDS | Sensor, Glucose, Invasive | ||
| My Dose Coach | Sanofi, Inc. | K163099 | 3/22/2017 | NDC | Calculator, Drug Dose | 868.1890 | Predictive pulmonary-function value calculator. |
| GoSpiro | MONITORED THERAPEUTICS, INC. | K163249 | 3/24/2017 | BZG | Spirometer, Diagnostic | 868.1840 | Diagnostic spirometer. |
| LISA | Siemens Medical Solutions USA, Inc. | K163297 | 3/24/2017 | JAK | System, X-Ray, Tomography, Computed | 892.1750 | Computed tomography x-ray system. |
| BewellConnect® MyTensio Bluetooth blood pressure monitor | Shenzhen Kingyield Technology Co., Ltd | K161530 | 3/31/2017 | DXN | system, measurement, blood-pressure, non-invasive | 870.1130 | Noninvasive blood pressure measurement system. |
| Move Forward 3D Motion Simulation Service | Biomet Orthopedics | K162559 | 3/31/2017 | LLZ | System, image processing, radiological | 892.2050 | Picture archiving and communications system. |
| eRAD PACS and eRAD RIS/PACS | eRAD, Inc., | K161341 | 4/5/2017 | LLZ | System, image processing, radiological | 892.2050 | Picture archiving and communications system. |
| Smart Dongle Blood Glucose Monitoring System | TaiDoc Technology Corporation | K162382 | 4/14/2017 | NBW | system, test, blood glucose, over the counter | 862.1345 | Glucose test system. |
| Cliniview | Palodex Group Oy | K162799 | 4/25/2017 | LLZ | System, image processing, radiological | 892.2050 | Picture archiving and communications system. |
| Gauss Surgical Triton Sponge System | Gauss Surgical, Inc. | K163507 | 4/25/2017 | PBZ | Image Processing Device For Estimation Of External Blood Loss | 880.2750 | (no description) |
| NuVasive® NuvaLine™ Mobile App | NuVasive, Incorporated | K162647 | 5/1/2017 | LLZ | System, image processing, radiological | 892.2050 | Picture archiving and communications system. |
| A&D Engineering, Inc. | A&D Medical UA-1200BLE UltraConnect Digital Blood Pressure Monitor | K163683 | 5/3/2017 | DXN | system, measurement, blood-pressure, non-invasive | 870.1130 | Noninvasive blood pressure measurement system. |
| Picture Archibing & Communications System (PACS) | NucleusHealth, LLC | K171130 | 5/4/2017 | LLZ | System, image processing, radiological | 892.2050 | Picture archiving and communications system. |
| SurgiCase Viewer | Materialise N.V. | K170419 | 5/11/2017 | LLZ | System, image processing, radiological | 892.2050 | Picture archiving and communications system. |
| A&D Engineering, Inc. | A&D Medical UA-1200BLE UltraConnect Digital Blood Pressure Monitor | K170196 | 5/17/2017 | DXN | system, measurement, blood-pressure, non-invasive | 870.1130 | Noninvasive blood pressure measurement system. |
| Scientific Intake | Sensor Monitored Alimentary Restriction Therapy (“SmartByte”) Device | K171165 | 5/18/2017 | ONY | Oral Removable Retainer For Weight Management | 876.5981 | A removable oral device used during meals to limit food intake. |
| Eko Devices, Inc. | Eko Model E5 (EME5) | K170874 | 5/19/2017 | DQD | Stethoscope, electronic | 870.1875 | Stethoscope |
| DEXCOM G4 PLATINUM CONTIUOUS GLUCOSE MONITORING SYSTEM, DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM | DEXCOM, INC. | P120005/S059 | 5/22/2017 | MDS | Sensor, Glucose, Invasive | ||
| Skylit Phototherapy System | Skylit Medical | K170489 | 5/23/2017 | FTC | Light, Ultraviolet, Dermatological | 878.4630 | Ultraviolet lamp for dermatologic disorders. |
| Etiometry, Inc. | T3 Software | K163065 | 5/26/2017 | PLB | Multivariate Vital Signs Index | 870.2300 | Cardiac monitor (including cardiotachometer and rate alarm). |
| Sanofi Aventis US LLC. | My Dose Coach | K171230 | 5/26/2017 | NDC | Calculator, Drug Dose | 868.1890 | Predictive pulmonary-function value calculator. |
| Contect Medical Systems Co., LTD | Portable ECG Monitor | K170954 | 5/30/2017 | DPS | Electrocardiograph | 870.2340 | Electrocardiograph. |
| Siemens Healthcare GmbH | Syngo Dynamics Version VA30 | K171053 | 6/1/2017 | LLZ | System, image processing, radiological | 892.2050 | Picture archiving and communications system. |
| iRhythm Technologies, Inc. | Zio AT ECG Monitoring | K163512 | 6/2/2017 | DSI | detector and alarm, arrhythmia | 870.1025 | Arrhythmia detector and alarm (including ST-segment measurement and alarm). |
| Vital Connect, Inc. | VitalWatch | K170973 | 6/2/2017 | DRG | transmitters and receivers, physiological signal, radiofrequency | 870.2910 | Radiofrequency physiological signal transmitter and receiver. |
| Siemens Healthcare GmbH | Syngo Dynamics Version VA30 | K171053 | 6/1/2017 | LLZ | System, image processing, radiological | 892.2050 | Picture archiving and communications system. |
| iRhythm Technologies, Inc. | Zio AT ECG Monitoring | K163512 | 6/2/2017 | DSI | detector and alarm, arrhythmia | 870.1025 | Arrhythmia detector and alarm (including ST-segment measurement and alarm). |
| Vital Connect, Inc. | VitalWatch | K170973 | 6/2/2017 | DRG | transmitters and receivers, physiological signal, radiofrequency | 870.2910 | Radiofrequency physiological signal transmitter and receiver. |
| Insulia Diabetes Management Companion | Voluntis S.A. | K170669 | 6/19/2017 | NDC | Calculator, Drug Dose | 868.1890 | Predictive pulmonary-function value calculator. |
| ImPACT Quick Test | ImPACT Applications, Inc. | K170551 | 6/21/2017 | POM | Computerized Cognitive Assessment Aid for Concussion | 882.1471 | Computerized cognitive assessment aid for concussion |
| CoVa Monitoring System 2 | toSense, Inc. | K160899 | 6/22/2017 | MWI | monitor,physiological,patient(without arrhythmia detection or alarms) | 870.2300 | Cardiac monitor (including cardiotachometer and rate alarm). |
| Enterprise Imaging XERO Viewer | Agfa HealthCare N.V. | K170434 | 7/3/2017 | LLZ | System, image processing, radiological | 892.2050 | Picture archiving and communications system. |
| ViMove2 | dorsaVi Ltd | K163150 | 7/14/2017 | IKN | Electromyograph, Diagnostic | 890.1375 | Diagnostic electromyograph. |
| Dario® Blood Glucose Monitoring System | LabStyle Innovations | K163159 | 7/19/2017 | NBW | system, test, blood glucose, over the counter | 862.1345 | Glucose test system. |
| Vital Images, Inc. | Vitrea Enterprise Viewer | K163232 | 7/21/2017 | LLZ | System, image processing, radiological | 892.2050 | Picture archiving and communications system. |
| NovaPACS | Novarad Corporation | K171754 | 7/28/2017 | LLZ | System, image processing, radiological | 892.2050 | Picture archiving and communications system. |
| LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3L | LifeWatch Services, Inc | K170565 | 8/1/2017 | DSI | detector and alarm, arrhythmia | 870.1025 | Arrhythmia detector and alarm (including ST-segment measurement and alarm). |
| BP5S Wireless Blood Pressure Monitor | Andon Health Co., Ltd. | K171062 | 8/1/2017 | DXN | system, measurement, blood-pressure, non-invasive | 870.1130 | Noninvasive blood pressure measurement system. |
| Hearing Healthcare Pro | DB Diagnostic Systems, Inc. | K171038 | 8/2/2017 | ETY | Tester, Auditory Impedance | 874.1090 | Auditory impedance tester. |
| Clarity Reveal | Ceevra, Inc. | K171356 | 8/3/2017 | LLZ | System, image processing, radiological | 892.2050 | Picture archiving and communications system. |
| OmniTom | NeuroLogica Corporation | K171183 | 8/18/2017 | JAK | System, X-Ray, Tomography, Computed | 892.1750 | Computed tomography x-ray system. |
| Optum TeleHealth Application | United Health Group Inc. | K171406 | 8/18/2017 | DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | 870.2910 | Radiofrequency physiological signal transmitter and receiver. |
| Physiotrace | NimbleHeart, Inc. | K171244 | 8/23/2017 | DRX | Electrode, Electrocardiograph | 870.2360 | Electrocardiograph electrode. |
| Microlife Upper Arm Automatic Digital Blood Pressure Monitor | Microlife Intellectual Property GmbH | K170467 | 8/30/2017 | DXN | System, Measurement, Blood-Pressure, Non-Invasive | 870.1130 | Noninvasive blood pressure measurement system. |
| GrindCare System | SUNSTAR SUISSE S.A. | K163448 | 9/1/2017 | HCC | Device, Biofeedback | 882.5050 | Biofeedback device. |
| Prizma | G-Medical Innovations Ltd. | K170181 | 9/1/2017 | DXH | Transmitters And Receivers, Electrocardiograph, Telephone | 870.2920 | Telephone electrocardiograph transmitter and receiver. |
| Poseidon Ultrasound System | BUTTERFLY NETWORK, INC. | K163510 | 9/6/2017 | IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 892.1550 | Ultrasonic pulsed doppler imaging system. |
| Indego | Parker Hannifin Corporation | K171334 | 9/8/2017 | PHL | Powered Exoskeleton | 890.3480 | Powered lower extremity exoskeleton. |
| Clarius Ultrasound System | Clarius Mobile Health Corp. | K172385 | 9/14/2017 | IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 892.1550 | Ultrasonic pulsed doppler imaging system. |
| WowGoHealth Blood Glucose Monitoring System | Biotest Medical Corporation | K171785 | 9/15/2017 | NBW | system, test, blood glucose, over the counter | 862.1345 | Glucose test system. |
| Scanostics UTI Check Application Test System | Teco Diagnostics | K170118 | 9/21/2017 | JMT | Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | 862.1510 | Nitrite (nonquantitative) test system. |
| Persyst Mobile App | Persyst Development Corporation | K171184 | 9/21/2017 | OMB | Automatic Event Detection Software For Full-Montage Electroencephalograph | 882.1400 | Electroencephalograph. |
| WiTouch Pro, WiTouch, Neubac | Hollywog LLC | K171599 | 9/22/2017 | NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | 882.5890 | Transcutaneous electrical nerve stimulator for pain relief. |
| Peerbridge Cor(TM) System | Peerbridge Health INc. | K171936 | 9/27/2017 | DSH | Recorder, Magnetic Tape, Medical | 870.2800 | Medical magnetic tape recorder. |
| Confirm Rx Insertable Cardiac Monitor (ICM) System | St. Jude Medical, Inc. | K163407 | 9/29/2017 | MXC | Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection) | 870.2800 | Medical magnetic tape recorder. |
| Carbon Monoxide Breath Sensor System (COBSS) | Carrot Sense, Inc. | K171408 | 9/29/2017 | CCJ | Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase | 868.1430 | Carbon monoxide gas analyzer. |
| ECG Check - Universal, ECG Check - Universal Plus | Cardiac Designs, Inc. | K170506 | 10/2/2017 | DXH | Transmitters And Receivers, Electrocardiograph, Telephone | 870.2920 | Telephone electrocardiograph transmitter and receiver. |
| MSA100BT Peak Flow Meter | Beijing M&B Electronic Instruments Co., Ltd. | K170281 | 10/6/2017 | BZH | Meter, Peak Flow, Spirometry | 868.1860 | Peak-flow meter for spirometry. |
| Higi Station (With Body Composition And Pan And Tilt Cuff Housing), Higi Station ( With Body Composition And Fixed Cuff Housing) | Higi SH LLC | K172739 | 10/10/2017 | DXN | system, measurement, blood-pressure, non-invasive | 870.1130 | Noninvasive blood pressure measurement system. |
| SONON Ultrasound Imaging System, Model: 300L | HEALCERION CO., LTD | K170085 | 10/12/2017 | IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 892.1550 | Ultrasonic pulsed doppler imaging system. |
| ECG SENTINEL System | Cardiomedix, Inc. | K172801 | 10/18/2017 | DXH | Transmitters And Receivers, Electrocardiograph, Telephone | 870.2920 | Telephone electrocardiograph transmitter and receiver. |
| Avail | Omron Healthcare, Inc. | K172079 | 10/19/2017 | NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | 882.5890 | Transcutaneous electrical nerve stimulator for pain relief. |
| DentureID Microchip | CMP Industries LLC | K170423 | 10/25/2017 | PYQ | Rfid Chip For Dental Appliance | 880.6300 | Implantable radiofrequency transponder system for patient identification and health information. |
| Biim Diagnostic Ultrasound System | Biim Ultrasound AS | K173138 | 10/27/2017 | IYO | System, Imaging, Pulsed Echo, Ultrasonic | 892.1560 | Ultrasonic pulsed echo imaging system. |
| Stethee Pro | M3dicine Pty. Ltd. | K172296 | 10/30/2017 | DQD | Stethoscope, Electronic | 870.1875 | Stethoscope. |
| Mytens Model: BW-TSX | Bewell Connect Corp. | K171026 | 43040 | NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | 882.589 | Transcutaneous electrical nerve stimulator for pain relief. |
| JiveX | VISUS TECHNOLOGY TRANSFER GMBH | K162008 | 9/16/2016 | LLZ | System, image processing, radiological | 892.2050 | Picture archiving and communications system. |
| SOFTNETA UAB | MedDream | K162011 | 10/14/2016 | LLZ | System, image processing, radiological | 892.2050 | Picture archiving and communications system. |
| IntelliSpace Portal Platform | PHILIPS MEDICAL SYSTEMS NEDERLANDS B.V. | K162025 | 10/18/2016 | LLZ | System, image processing, radiological | 892.2050 | Picture archiving and communications system. |
| Full Automatic (NIBP) Blood Pressure Monitor | HEALTH & LIFE CO., LTD. | K162338 | 9/21/2016 | DXN | System, measurement, blood-pressure, non-invasive | 870.1130 | Noninvasive blood pressure measurement system. |
| Lumify Ultrasound System | Philips Healthcare | K162549 | 10/3/2016 | IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 892.1550 | Ultrasonic pulsed doppler imaging system. |
| CALGARY SCIENTIFIC, INC. | CALGARY SCIENTIFIC, INC. | K161130 | 8/24/2016 | LLZ | System, image processing, radiological | 870.2300 | Cardiac monitor (including cardiotachometer and rate alarm). |
| CareEvent inclusive of the CareEvent Mobile Application accessory | PHILIPS MEDICAL SYSTEMS | K161164 | 6/24/2016 | MSX | System, network and communication, physiological monitors | 870.2300 | Cardiac monitor (including cardiotachometer and rate alarm). |
| PC ECG | EDAN INSTRUMENTS, INC. | K161302 | 7/1/2016 | DPS | Electrocardiograph | 870.2340 | Electrocardiograph. |
| CliniCloud Non-contact Thermometer, Model SPL1024 | STETHOCLOUD PTY. LTD (CLINICLOUD) | K161325 | 6/22/2016 | FLL | Thermometer, Electronic, Clinical | 880.2910 | Clinical electronic thermometer. |
| CardioConfirm | MORTARA INSTRUMENT, INC. | K161465 | 9/3/2016 | DQK | Computer, diagnostic, programmable | 870.1425 | Programmable diagnostic computer. |
| CUSTOMIZED SOUND THERAPY (CST) | TINNITUS OTOSOUND PRODUCTS, LLC | K070599 | 7/13/2007 | KLW | masker, tinnitus | 874.3400 | Tinnitus masker. |
| Synapse 3D Liver and Kidney Analysis | FUJIFILM MEDICAL SYSTEMS U.S.A., INC. | K142521 | 12/1/2014 | LLZ | System, image processing, radiological | 892.2050 | Picture archiving and communications system. |
| AirStrip ONE Web RPM Software | AIRSTRIP TECHNOLOGIES, INC. | K160073 | 3/24/2016 | MWI | Monitor, physiological, patient (without arrhythmia detection or alarms) | 870.2300 | Cardiac monitor (including cardiotachometer and rate alarm). |
| AirStrip RPM | AirStrip Technologies, Inc. | K160862 | 9/19/2016 | MSX | System, network and communication, physiological monitors | 870.2300 | Cardiac monitor (including cardiotachometer and rate alarm). |
| AGFA HEALTHCARE N.V. | AGFA HEALTHCARE N.V. | K161061 | 6/22/2016 | LLZ | System, image processing, radiological | 892.2050 | Picture archiving and communications system. |
| DENTSPLY SIRONA | DENTSPLY SIRONA | K161118 | 7/28/2016 | LLZ | System, image processing, radiological | 892.2050 | Picture archiving and communications system. |
| CALGARY SCIENTIFIC, INC. | CALGARY SCIENTIFIC, INC | K161130 | 8/24/2016 | LLZ | System, image processing, radiological | 892.2050 | Picture archiving and communications system. |
| NuVasiveNVM5 System | NUVASIVE INCORPORATED | K152942 | 2016/01/13 | PDQ | Neurosurgical Nerve Locator | 874.1820 | Surgical nerve stimulator/locator. |
| Quell | NEUROMETRIX, INC. | K152954 | 2016/01/05 | NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | 882.5890 | Transcutaneous electrical nerve stimulator for pain relief. |
| Microlife Upper Arm Automatic Digital Blood Pressure Monitor | MICROLIFE INTELLECTUAL PROPERTY GMBH | K153077 | 2016/02/12 | DXN | System, measurement, blood-pressure, non-invasive | 870.1130 | Noninvasive blood pressure measurement system. |
| AlertWatch: OR | ALERTWATCH LLC | K153335 | 2016/03/15 | MWI | Monitor, physiological, patient (without arrhythmia detection or alarms) | 870.2300 | Cardiac monitor (including cardiotachometer and rate alarm). |
| Electronic Pulse Stimulator | JKH HEALTH CO.,LTD. | K153520 | 2016/05/05 | NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | 882.5890 | Transcutaneous electrical nerve stimulator for pain relief. |
| Wireless Earlens Light Driven Hearing Aid | EARLENS CORPORATION | K153634 | 2016/04/06 | PLK | Tympanic Membrane Direct Contact Hearing Aid | 874.3315 | |
| DICOM Viewer | Brainlab AG | K153653 | 2016/04/13 | LLZ | System, image processing, radiological | 892.2050 | Picture archiving and communications system. |
| TraumaCad Mobile Release 2.0 | Voyant Health Ltd | K160001 | 2016/02/12 | LLZ | System, image processing, radiological | 892.2050 | Picture archiving and communications system. |
| IHealth Track Blood Pressure Monitor | Andon Health Co., Ltd | K160014 | 2016/02/02 | DXN | System, measurement, blood-pressure, non-invasive | 870.1130 | Noninvasive blood pressure measurement system. |
| CUR Model 1 | Thimble Bioelectronics, Inc. | K160052 | 2016/05/20 | NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | 882.5890 | Transcutaneous electrical nerve stimulator for pain relief. |
| Full Automatic (NIBP) Blood Pressure Monitor | Health & Life Co., Ltd. | K160145 | 2016/03/13 | DXN | System, measurement, blood-pressure, non-invasive | 870.1130 | Noninvasive blood pressure measurement system. |
| Reveal LINQ | MEDTRONIC, INC. | K160809 | 2016/05/26 | DSI | Detector and alarm, arrhythmia | 870.1025 | Arrhythmia detector and alarm (including ST-segment measurement and alarm). |
| ACCU-CHEK Connect Diabetes Management App | ROCHE DIAGNOSTICS CORPORATION | K141929 | 2015/03/16 | NDC | calculator, drug dose | 868.1890 | Predictive pulmonary-function value calculator. |
| ACCU-CHEK Connect Diabetes Management App | ROCHE DIABETES CARE INC. | K150910 | 2015/06/03 | NDC | calculator, drug dose | 868.1890 | Predictive pulmonary-function value calculator. |
| S HEALTH | SAMSUNG ELECTRONICS CO., LTD | K132148 | 2013/12/04 | DRG | Transmitters and receivers, physiological signal, radiofrequency | 870.2910 | Radiofrequency physiological signal transmitter and receiver. |
| GLOOKO DEVICE SYSTEM FOR GLOOKO APPLICATION | GLOOKO, INC | K132272 | 2013/10/17 | NBW | System, test, blood glucose, over the counter | 862.1345 | Glucose test system. |
| ZOLL CODE WRITER | ZOLL MEDICAL CORPORATION | K132488 | 2014/04/03 | DXJ | Display, cathode-ray tube, medical | 870.2450 | Medical cathode-ray tube display. |
| MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM, HEALTHPAL, HEALTHCOM, MOBILE LINK | MEDAPPS INC., DBA ALERE CONNECT | K132803 | 2013/12/12 | DRG | Transmitters and receivers, physiological signal, radiofrequency | 870.2910 | Radiofrequency physiological signal transmitter and receiver. |
| AGAMATRIX HEALTH MANAGER | AGAMATRIX INC | K132821 | 2013/11/20 | NBW | System, test, blood glucose, over the counter | 862.1345 | Glucose test system. |
| NOVAPACS | NOVARAD CORP. | K132853 | 2014/10/30 | LLZ | System, image processing, radiological | 892.2050 | Picture archiving and communications system. |
| MYHEALTHPOINT TELEHEALTH MANAGER | ENTRA HEALTH SYSTEMS | K132930 | 2014/04/14 | DRG | Transmitters and receivers, physiological signal, radiofrequency | 870.2910 | Radiofrequency physiological signal transmitter and receiver. |
| WITHINGS BLOOD PRESURE MONITOR | WITHINGS | K133125 | 2014/03/24 | DXN | System, measurement, blood-pressure, non-invasive | 870.1130 | Noninvasive blood pressure measurement system. |
| IMPAX VOLUME VIEWING 3.0 | AGFA HEALTHCARE N.V. | K133135 | 2014/03/07 | LLZ | System, image processing, radiological | 892.2050 | Picture archiving and communications system. |
| HEALTHINTERLINK BEACON | HEALTHINTERLINK, LLC | K133252 | 2014/03/14 | DRG | Transmitters and receivers, physiological signal, radiofrequency | 870.2910 | Radiofrequency physiological signal transmitter and receiver. |
| AIRSTRIP REMOTE PATIENT MONITORING | AIRSTRIP TECHNOLOGIES, LP | K133394 | 2014/02/06 | MWI | Monitor, physiological, patient (without arrhythmia detection or alarms) | 870.2300 | Cardiac monitor (including cardiotachometer and rate alarm). |
| AIRSTRIP REMOTE PATIENT MONITORING | AIRSTRIP TECHNOLOGIES, LP | K133450 | 2014/02/14 | MWI | Monitor, physiological, patient (without arrhythmia detection or alarms) | 870.2300 | Cardiac monitor (including cardiotachometer and rate alarm). |
| RESOLUTIONMD MOBILE | CALGARY SCIENTIFIC, INC | K133508 | 2014/03/26 | LLZ | System, image processing, radiological | 892.2050 | Picture archiving and communications system. |
| MCKESSON CARDIOLOGY ECG MOBILE | MCKESSON ISRAEL LTD | K133534 | 2014/04/18 | DQK | Computer, diagnostic, programmable | 870.1425 | Programmable diagnostic computer. |
| FORA CARE BLOOD PRESSURE MONITORING SYSTEM | FORA CARE INC. | K133588 | 2014/04/25 | DXN | System, measurement, blood-pressure, non-invasive | 870.1130 | Noninvasive blood pressure measurement system. |
| PHYSIOGLOVE ET SYSTEM | COMMWELL R&D LTD. | K133703 | 2014/08/18 | DXH | Transmitters and receivers, electrocardiograph, telephone | 870.2920 | Telephone electrocardiograph transmitter and receiver. |
| MOME ECG CONTINUOUS DETECTION AND ARRHYTHMIA DETECTOR | INFOBIONIC, INC | K133753 | 2014/09/19 | DSI | Detector and alarm, arrhythmia | 870.1025 | Arrhythmia detector and alarm (including ST-segment measurement and alarm). |
| IHEALTH ALIGN MINI GLUCO-MONITORING SYSTEM | ANDON HEALTH CO., LTD | K133790 | 2014/05/22 | NBW | System, test, blood glucose, over the counter | 862.1345 | Glucose test system. |
| VERIZON WIRELESS CONVERGED HEALTH MANAGEMENT DEVICE | CELLCO PARTNERSHIP D/B/A VERIZON WIRELESS | K134004 | 2014/02/14 | DRG | Transmitters and receivers, physiological signal, radiofrequency | 870.2910 | Radiofrequency physiological signal transmitter and receiver. |
| TEMPUS PRO ACCESSORIES (ULTRASOUND & VIDEO LARYNGOSCOPE PROBE) | REMOTE DIAGNOSTIC TECHNOLOGIES LTD. | K134014 | 2014/08/12 | MWI | monitor, physiological, patient (without arrhythmia detection or alarms) | 870.2300 | Cardiac monitor (including cardiotachometer and rate alarm). |
| EXTERNAL PULSE OXIMETER | BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. | K141024 | 2015/01/13 | DQA | Oximeter | 870.2700 | Oximeter |
| VITALCONNECT PLATFORM (CONSISTING OF VITALCONNECT SENSOR, RELAY SOFTWARE LIBRARY AND SECURE SERVER SOFTWARE LIBRARY) | VITAL CONNECT INC. | K141167 | 2014/07/29 | DRG | Transmitters and receivers, physiological signal, radiofrequency | 870.2910 | Radiofrequency physiological signal transmitter and receiver. |
| ECARE COORDINATOR (ECC) | VISICU, INC. | K141706 | 2014/09/09 | DRG | Transmitters and receivers, physiological signal, radiofrequency | 870.2910 | Radiofrequency physiological signal transmitter and receiver. |
| DECISIO HEALTH PATIENT DASHBOARD | DECISIO HEALTH, INC. | K142106 | 2015/01/18 | MWI | Monitor, physiological, patient (without arrhythmia detection or alarms) | 870.2300 | Cardiac monitor (including cardiotachometer and rate alarm). |
| Visage Ease Pro | VISAGE IMAGING GMBH | K142196 | 2015/04/28 | LLZ | System, image processing, radiological | 892.2050 | Picture archiving and communications system. |
| CardiacLinx | Ross Medical Technology, Inc | K142352 | 2015/03/12 | DSI | Detector and alarm, arrhythmia | 870.1025 | Arrhythmia detector and alarm (including ST-segment measurement and alarm). |
| Master Caution Device MCD | HealthWatch Ltd. | K142476 | 2015/02/17 | DXH | Transmitters and receivers, electrocardiograph, telephone | 870.2920 | Telephone electrocardiograph transmitter and receiver. |
| SPINEDESIGN Spine Surgery Planning (Software Application) | MEDTRONIC SOFAMOR DANEK USA, INC | K142648 | 2015/05/22 | LLZ | System, image processing, radiological | 892.2050 | Picture archiving and communications system. |
| AliveCor Heart Monitor | AliveCor, Inc. | K142743 | 2015/01/27 | DXH | Transmitters and receivers, electrocardiograph, telephone | 870.2920 | Telephone electrocardiograph transmitter and receiver. |
| Pulse Oximeter | Shanghai Berry Electronic Tech Co., Ltd | K142687 | 2015/04/13 | DQA | Oximeter | 870.2700 | Oximeter |
| JiveX | VISUS TECHNOLOGY TRANSFER GMBH | K142750 | 2015/06/26 | LLZ | System, image processing, radiological | 892.2050 | Picture archiving and communications system. |
| Triton Canister System | Gauss Surgical, Inc. | K142801 | 2015/03/12 | PBZ | Image Processing Device For Estimation Of External Blood Loss | 880.2750 | |
| TraumaCad Mobile Release 1.0 | Voyant Health Ltd | K142923 | 2015/03/05 | LLZ | System, image processing, radiological | 892.2050 | Picture archiving and communications system. |
| Vyntus Walk | CAREFUSION GERMANY 234 GMBH | K142959 | 2015/03/20 | DQA | Oximeter | 870.2700 | Oximeter |
| Propeller System 2014-R | Reciprocal Labs | K142960 | 2015/03/05 | CAF | Nebulizer (Direct Patient Interface) | 868.5630 | Nebulizer |
| eMotion Faros ECG Mobile | MEGA ELECTRONICS LTD | K143032 | 2015/03/29 | DXH | Transmitters and receivers, electrocardiograph, telephone | 870.2920 | Telephone electrocardiograph transmitter and receiver. |
| Sense4Baby System Model B+ (MSA) | AIRSTRIP TECHNOLOGIES, INC | K143114 | 2015/03/10 | LQK | Home Uterine Activity Monitor | 884.2730 | Home uterine activity monitor. |
| UltraLinq | ULTRALINQ HEALTHCARE SOLUTIONS, INC. | K143176 | 2015/07/17 | LLZ | System, image processing, radiological | 892.2050 | Picture archiving and communications system. |
| myVision Track Model 005 | VITAL ART AND SCIENCE INCORPORATED | K143211 | 2015/03/20 | HPT | Perimeter, Automatic, Ac-Powered | 886.1330 | |
| TempTraq TT-100 | Blue Spark Technologies Inc | K143267 | 2015/09/02 | FLL | Thermometer, Electronic, Clinical | 880.2910 | Clinical electronic thermometer. |
| CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector | LifeWatch Technologies Ltd | K143359 | 2015/09/11 | DSI | Detector and alarm, arrhythmia | 870.1025 | Arrhythmia detector and alarm (including ST-segment measurement and alarm). |
| ICIS View | Agfa HealthCare N.V. | K143397 | 2015/06/01 | LLZ | System, image processing, radiological | 892.2050 | Picture archiving and communications system. |
| SmartTENS | EASYMED INSTRUMENT CO., LTD. | K143430 | 2015/05/29 | NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | 882.5890 | Transcutaneous electrical nerve stimulator for pain relief. |
| InvisionECG System | InvisionHeart Inc. | K143436 | 2015/05/21 | DPS | Electrocardiograph | 870.2340 | Electrocardiograph. |
| NFANT Feeding Solution | NFANT Labs, LLC | K143507 | 2015/09/09 | HCC | Device, Biofeedback | 882.5050 | Biofeedback device. |
| PeriCoach | ANALYTICA LTD | K143580 | 2015/03/18 | HIR | Perineometer | 884.1425 | Perineometer. |
| Propeller Model 2014-D Sensor | Reciprocal Labs | K143671 | 2015/06/19 | CAF | Nebulizer (Direct Patient Interface) | 868.5630 | Nebulizer |
| Gmate SMART Blood Glucose Monitoring System | Philosys Inc | K150299 | 2015/11/19 | NBW | System, test, blood glucose, over the counter | 862.1345 | Glucose test system. |
| Masimo MightySat Rx Fingertip Pulse Oximeter | MASIMO CORPORATION | K150314 | 2015/10/22 | DQA | Oximeter | 870.2700 | Oximeter |
| NilRead | Perceptive Software | K150415 | 2015/06/12 | LLZ | System, image processing, radiological | 892.2050 | Picture archiving and communications system. |
| Arm Blood Pressure Monitor, Wrist Blood Pressure Monitor | FUDAKANG INDUSTRIAL CO., LTD | K150430 | 2015/04/17 | DXN | System, measurement, blood-pressure, non-invasive | 870.1130 | Noninvasive blood pressure measurement system. |
| Proteus Digital Health Feedback Device | PROTEUS DIGITAL HEALTH, INC | K150494 | 2015/06/27 | OZW | Ingestible Event Marker | 880.6305 | Ingestible event marker. |
| Reveal LINQ | MEDTRONIC INC. | K150614 | 2015/08/06 | DSI | Detector and alarm, arrhythmia | 870.1025 | Arrhythmia detector and alarm (including ST-segment measurement and alarm). |
| Spaulding Electrocardiograph 2100iQ | Spaulding Clinical Research, LLC | K150564 | 2015/08/12 | DPS | Electrocardiograph | 870.2340 | Electrocardiograph. |
| zensor system | INTELESENS LIMITED | K151027 | 2015/10/02 | MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 870.1025 | Arrhythmia detector and alarm (including ST-segment measurement and alarm). |
| Philips Self-Adhesive Electrodes | PHILIPS CONSUMER LIFESTYLE | K151033 | 2015/07/28 | GXY | Electrode, Cutaneous | 882.1320 | Cutaneous electrode. |
| PainKARE | TrioWave Technologies | K151034 | 2015/11/21 | NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | 882.5890 | Transcutaneous electrical nerve stimulator for pain relief. |
| SmartLinx Vitals Plus Patient Monitoring System | CAPSULE TECHNOLOGIE SAS | K151071 | 2015/09/17 | MWI | Monitor, physiological, patient (without arrhythmia detection or alarms) | 870.2300 | Cardiac monitor (including cardiotachometer and rate alarm). |
| MiniMed Connect kit, MiniMed Connect uploader, MiniMed Connect app, CareLink Connect (CareLink Personal) | MEDTRONIC MINIMED, INC. | K151236 | 2015/05/19 | PJT | Continuous Glucose Monitor Secondary Display | 862.1350 | |
| Eko Electronic Stethoscope System | Eko Devices, Inc. | K151319 | 2015/08/28 | DQD | stethoscope, electronic | 870.1875 | Stethoscope |
| Dentrix Ascend Imaging | REALCLOUD IMAGING INC. | K151438 | 2015/07/07 | LLZ | System, image processing, radiological | 892.2050 | Picture archiving and communications system. |
| Microlife Upper Arm Automatic Digital Blood Pressure Monitor | MICROLIFE INTELLECTUAL PROPERTY GMBH, SWITZERLAND | K151869 | 2015/09/02 | DXN | System, measurement, blood-pressure, non-invasive | 870.1130 | Noninvasive blood pressure measurement system. |
| CARESTREAM Vue Motion | CARESTREAM HEALTH, INC | K151774 | 2015/09/21 | LLZ | System, image processing, radiological | 892.2050 | Picture archiving and communications system. |
| Slendertone connect Abs | BIO-MEDICAL RESEARCH LTD. | K151903 | 2015/11/06 | NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | 890.5850 | Powered muscle stimulator. |
| iHealth BP3L Wireless Blood Pressure Monitor | ANDON HEALTH CO.,LTD | K152003 | 2015/09/24 | DXN | System, measurement, blood-pressure, non-invasive | 870.1130 | Noninvasive blood pressure measurement system. |
| iHealth View BP7S Wireless Blood Pressure Wrist Monitor | ANDON HEALTH CO.,LTD | K152379 | 2015/09/23 | DXN | System, measurement, blood-pressure, non-invasive | 870.1130 | Noninvasive blood pressure measurement system. |
| M9/M9CV/M9T Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd | K152543 | 2015/10/29 | IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 892.1550 | Ultrasonic pulsed doppler imaging system. |
| Philips Lumify Diagnostic Ultrasound System | PHILIPS HEALTHCARE, INC. | K152899 | 2015/10/30 | IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 892.1550 | Ultrasonic pulsed doppler imaging system. |
| IHEALTH BG5/BG5L WIRELESS SMART GLUCOSE MONITORING SYSTEM | ANDON MEDICAL CO., LTD | K123935 | 2013/04/12 | NBW | System, test, blood glucose, over the counter | 862.1345 | Glucose test system. |
| ALIVECOR HEART MONITOR | ALIVECOR, INC. | K130409 | 2013/09/06 | DPS | Electrocardiograph | 870.2340 | Electrocardiograph. |
| ISIRONA MAGELLAN | ISIRONA, LLC | K130707 | 2013/11/20 | MSX | System,network and communication,physiological monitors | 870.2300 | Cardiac monitor (including cardiotachometer and rate alarm). |
| VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM | COVIDIEN | K130796 | 2013/05/09 | MWI | Monitor, physiological, patient (without arrhythmia detection or alarms) | 870.2300 | Cardiac monitor (including cardiotachometer and rate alarm). |
| OPTUM TELEHEALTH APPLICATION | OPTUMHEALTH CARE SOLUTIONS, INC. | K130971 | 2013/10/23 | DRG | Transmitters and receivers, physiological signal, radiofrequency | 870.2910 | Radiofrequency physiological signal transmitter and receiver. |
| SENSICARDIAC MOBI DIAGNOSTIC HEART MURMUR APPLICATION | DIACOUSTIC MEDICAL DEVICES (PTY) LTD | K131044 | 2013/09/04 | DQD | Stethoscope, electronic | 870.1875 | Stethoscope |
| EMOTION ECG MOBILE | MEGA ELECTRONICS LTD | K131699 | 2013/11/26 | DXH | Transmitters and receivers, electrocardiograph, telephone | 870.2920 | Telephone electrocardiograph transmitter and receiver. |
| AIRSTRIP REMOTE PATIENT MONITORING PHILIPS ADAPTER | AIRSTRIP TECHNOLOGIES, LP | K131786 | 2013/07/03 | MWI | Monitor,physiological,patient(without arrhythmia detection or alarms) | 870.2300 | Cardiac monitor (including cardiotachometer and rate alarm). |
| AIDERA DIASEND SYSTEM | AIDERA AB | K101806 | 2010/12/07 | MRZ | accessories, pump, infusion | 880.5725 | Infusion pump. |
| AIRSTRIP OB | MP4 SOLUTIONS, LP | K042082 | 2005/01/21 | HGM | system, monitoring, perinatal | 884.2740 | Perinatal monitoring system and accessories. |
| AIRSTRIP OB | AIRSTRIP TECHNOLOGIES, LP | K090061 | 2009/01/23 | HGM | system, monitoring, perinatal | 884.2740 | Perinatal monitoring system and accessories. |
| AIRSTRIP OB | AIRSTRIP TECHNOLOGIES, LP | K090269 | 2009/02/13 | HGM | system, monitoring, perinatal | 884.2740 | Perinatal monitoring system and accessories. |
| AIRSTRIP REMOTE PATIENT MONITORING | AIRSTRIP TECHNOLOGIES, LP | K133450 | 2014/02/14 | MWI | Monitor, physiological, patient (without arrhythmia detection or alarms) | 870.2300 | Cardiac monitor (including cardiotachometer and rate alarm). |
| AIRSTRIP REMOTE PATIENT MONITORING (RPM) | AIRSTRIP TECHNOLOGIES, LP | K110503 | 2011/03/10 | MWI | monitor, physiological, patient (without arrhythmia detection or alarms) | 870.2300 | Cardiac monitor (including cardiotachometer and rate alarm). |
| AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING | AIRSTRIP TECHNOLOGIES, LP | K112235 | 2011/08/26 | MWI | monitor, physiological, patient (without arrhythmia detection or alarms) | 870.2300 | Cardiac monitor (including cardiotachometer and rate alarm). |
| AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING | AIRSTRIP TECHNOLOGIES, LP | K121871 | 2012/07/03 | MWI | monitor, physiological, patient (without arrhythmia detection or alarms) | 870.2300 | Cardiac monitor (including cardiotachometer and rate alarm). |
| AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING SOFTWARE, VERSION 3.1 | AIRSTRIP TECHNOLOGIES, LP | K100133 | 2010/07/23 | MWI | monitor, physiological, patient (without arrhythmia detection or alarms) | 870.2300 | Cardiac monitor (including cardiotachometer and rate alarm). |
| ALIVECOR HEART MONITOR | ALIVECOR INC. | K140933 | 2014/08/15 | DXH | Transmitters and receivers, electrocardiograph, telephone | 870.2920 | Telephone electrocardiograph transmitter and receiver. |
| AliveCor Heart Monitor | ALIVECOR INC. | K142672 | 2014/12/03 | DXH | Transmitters and receivers, electrocardiograph, telephone | 870.2920 | Telephone electrocardiograph transmitter and receiver. |
| ALIVECOR HEART MONITOR FOR IPHONE | ALIVECOR, INC. | K122356 | 2012/11/19 | DPS | electrocardiograph | 870.2340 | Electrocardiograph. |
| ALIVECOR HEART MONITOR OTC | ALIVECOR INC. | K130921 | 2014/02/06 | DPS | electrocardiograph | 870.2340 | Electrocardiograph. |
| ASTHMAPOLIS SYSTEM | RECIPROCAL LABS CORPORATION | K121609 | 2012/07/02 | CAF | nebulizer (direct patient interface) | 868.5630 | Nebulizer. |
| AVITA BLUETOOTH BLOOD PRESSURE MONITOR, MODEL: BPM656ZB | AVITA CORPORATION | K072137 | 2007/12/07 | DXN | system, measurement, blood-pressure, non-invasive | 870.1130 | Noninvasive blood pressure measurement system. |
| AYCAN MOBILE | AYCAN DIGITALSYSTEME GMBH | K122260 | 2012/09/12 | LLZ | System, image processing, radiological | 892.2050 | Picture archiving and communications system. |
| BEAM BRUSH/BEAM APP | BEAM TECHNOLOGIES, LLC | K121165 | 2012/06/21 | EFW | toothbrush, manual | 872.6855 | Manual toothbrush. |
| BECTON DICKINSON INTELLIPORT SYSTEM | BECTON, DICKINSON AND COMPANY | K141474 | 2014/12/18 | PHC | infusion safety management software | 880.5725 | Infusion pump. |
| BIOHARNESS | ZEPHYR TECHNOLOGY CORPORATION | K113045 | 2012/08/14 | MHX | monitor, physiological, patient(with arrhythmia detection or alarms) | 870.1025 | Arrhythmia detector and alarm (including ST-segment measurement and alarm). |
| BODYGUARDIAN SYSTEM BODYGUARDIAN CONTROL UNIT BODYGUARDIAN CONNECT | PREVENTICE, INC. | K121197 | 2012/08/10 | DSI | detector and alarm, arrhythmia | 870.1025 | Arrhythmia detector and alarm (including ST-segment measurement and alarm). |
| CARESTREAM PACS | CARESTREAM HEALTH, INC. | K110919 | 2011/10/20 | LLZ | System, image processing, radiological | 892.2050 | Picture archiving and communications system. |
| CARESTREAM VUE PACS VERSION 11.4 CARESTREAM VUE MOTION APPLICATION | CARESTREAM HEALTH INC. | K132824 | 2014/02/06 | LLZ | System, image processing, radiological | 892.2050 | Picture archiving and communications system. |
| CG-5108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR | CARD GUARD SCIENTIFIC SURVIVAL LTD. | K110499 | 2011/04/06 | DSI | detector and alarm, arrhythmia | 870.1025 | Arrhythmia detector and alarm (including ST-segment measurement and alarm). |
| CG-6108 ACT-3L CONTINUOUS ECG MONITOR & ARRHYTHMIA DETECTOR | CARD GUARD SCIENTIFIC SURVIVAL, LTD. | K081257 | 2008/05/29 | DSI | detector and alarm, arrhythmia | 870.1025 | Arrhythmia detector and alarm (including ST-segment measurement and alarm). |
| CG-6108 ACT-IL CONTINUOUS ECG MONITOR AND ARRYTHMIA DETECTOR | CARD GUARD SCIENTIFIC SURVIVAL, LTD. | K101639 | 2010/06/25 | DSI | detector and alarm, arrhythmia | 870.1025 | Arrhythmia detector and alarm (including ST-segment measurement and alarm). |
| CG-6108 ARRHYTHMIA ECG EVENT RECORDER | CARD GUARD SCIENTIFIC SURVIVAL, LTD. | K060911 | 2006/08/22 | DXH | transmitters and receivers, electrocardiograph, telephone | 870.2920 | Telephone electrocardiograph transmitter and receiver. |
| CG-6108 CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR | CARD GUARD SCIENTIFIC SURVIVAL, LTD. | K071995 | 2007/12/18 | DXH | transmitters and receivers, electrocardiograph, telephone | 870.2920 | Telephone electrocardiograph transmitter and receiver. |
| CONFIDANT 2.5 | CONFIDANT INC. | K072698 | 2007/11/16 | DRG | transmitters and receivers, physiological signal, radiofrequency | 870.2910 | Radiofrequency physiological signal transmitter and receiver. |
| DANA | ANTHROTRONIX, INC. | K141865 | 2014/10/15 | LQD | Pre-Amendment | ||
| DASH KNEE | BRAINLAB AG | K102251 | 2011/05/17 | OLO | orthopedic stereotaxic instrument | 882.4560 | Stereotaxic instrument. |
| DATEX-OHMEDA S/5 WEB VIEWER, DATEX-OHMEDA S/5 POCKET VIEWER AND DATEX-OHMEDA S/5 CELLULAR VIEWER WITH L-WEB04 SOFTWARE | GE HEALTHCARE | K052975 | 2006/01/20 | MSX | system,network and communication,physiological monitors | 870.2300 | Cardiac monitor (including cardiotachometer and rate alarm). |
| DCAS I | GP&P CO. | K140869 | 2014/07/03 | LLZ | System, image processing, radiological | 892.2050 | Picture archiving and communications system. |
| DIABETESMANAGER SYSTEM, DIABETESMANAGER-RX SYSTEM MODEL VERSION 1.1 | WELLDOC, INC | K100066 | 2010/07/15 | LNX | medical computers and software | Unclassified | Unclassified |
| EBM IDO VIEWER | EBM TECHNOLOGIES, INC. | K140399 | 2014/09/18 | LLZ | System, image processing, radiological | 892.2050 | Picture archiving and communications system. |
| ECARE COORDINATOR (ECC) | VISICU, INC. | K141706 | 2014/09/09 | DRG | Transmitters and receivers, physiological signal, radiofrequency | 870.2910 | Radiofrequency physiological signal transmitter and receiver. |
| FAMILY HEALTHWARE | SANITAS, INC. | K132173 | 2014/05/30 | DRG | Transmitters and receivers, physiological signal, radiofrequency | 870.2910 | Radiofrequency physiological signal transmitter and receiver. |
| FORA CARE BLOOD PRESSURE MONITORING SYSTEM | FOR A CARE INC. | K133588 | 2014/04/25 | DXN | System, measurement, blood-pressure, non-invasive | 870.1130 | Noninvasive blood pressure measurement system. |
| FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM | ABBOTT DIABETES CARE INC. | K020866 | 2002/06/11 | NBW | system, test, blood glucose, over the counter | 862.1345 | Glucose test system. |
| FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM | ABBOTT DIABETES CARE INC. | K020866 | 2002/06/11 | NBW | system, test, blood glucose, over the counter | 862.1345 | Glucose test system. |
| FRONTIER/ FRONTIER II /ANTHEM FAMILY OF CRT-P'S | ST. JUDE MEDICAL | P030035/S098 | 2014/04/10 | NKE | Pulse generator, pacemaker, implantable | ||
| FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-931 | ANDON HEALTH CO.,LTD | K102939 | 2011/02/23 | DXN | system, measurement, blood-pressure, non-invasive | 870.1130 | Noninvasive blood pressure measurement system. |
| FULLY AUTOMATIC WIRELESS BLOOD PRESSURE WRIST MONITOR | ANDON HEALTH CO., LTD | K121470 | 2012/06/14 | DXN | system, measurement, blood-pressure, non-invasive | 870.1130 | Noninvasive blood pressure measurement system. |
| GENESIS TOUCH SYSTEM | HONEYWELL HOMMED | K141792 | 2014/11/25 | DRG | Transmitters and receivers, physiological signal, radiofrequency | 870.2910 | Radiofrequency physiological signal transmitter and receiver. |
| GLUCOPHONE BLOOD GLUCOSE TEST SYSTEM, MODEL IGM-0025 | INFOPIA CO., LTD | K091168 | 2010/05/27 | NBW | system, test, blood glucose, over the counter | 862.1345 | Glucose test system. |
| HEALTH2SYNC MOBILE APPLICATION, HEALTH2SYNC SMART CABLE | H2 INC. | K141862 | 2014/12/02 | NBW | System, test, blood glucose, over the counter | 862.1345 | Glucose test system. |
| HEALTHINTERLINK BEACON | HEALTHINTERLINK, LLC | K133252 | 2014/03/14 | DRG | Transmitters and receivers, physiological signal, radiofrequency | 870.2910 | Radiofrequency physiological signal transmitter and receiver. |
| IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATION, REV D | AGAMATRIX INC | K103544 | 2011/12/07 | NBW | system, test, blood glucose, over the counter | 862.1345 | Glucose test system. |
| IDEAL LIFE GLUCO-MANAGER BLOOD GLUCOSE MONITORING SYSTEM | IDEAL LIFE INC. | K132180 | 2014/06/25 | NBW | System, test, blood glucose, over the counter | 862.1345 | Glucose test system. |
| IEVA REHABILITATIVE POSITIONAL DEVICE | REMENDIUM LABS, LLC | K133990 | 2014/10/09 | HIR | perineometer | 884.1425 | Perineometer. |
| IGLUCOSE SYSTEM | POSITIVEID CORPORATION | K111932 | 2011/11/10 | NBW | system, test, blood glucose, over the counter | 862.1345 | Glucose test system. |
| IHEALTH ALIGN MINI GLUCO-MONITORING SYSTEM | ANDON HEALTH CO., LTD. | K133790 | 2014/05/22 | NBW | System, test, blood glucose, over the counter | 862.1345 | Glucose test system. |
| IMCO-STAT | IMCO TECHNOLOGIES | K063392 | 2006/12/12 | LLZ | System, image processing, radiological | 892.2050 | Picture archiving and communications system. |
| IMPAX VOLUME VIEWING 3.0 | AGFA HEALTHCARE NV | K133135 | 2014/03/07 | LLZ | System, image processing, radiological | 892.2050 | Picture archiving and communications system. |
| INTUITION | TERARECON, INC. | K121916 | 2013/04/02 | LLZ | System, image processing, radiological | 892.2050 | Picture archiving and communications system. |
| KD-936 FULLY AUTOMATIC WIRELESS BLOOD PRESSURE MONITOR | ANDON HEALTH CO.,LTD | K120672 | 2012/06/01 | DXN | system, measurement, blood-pressure, non-invasive | 870.1130 | Noninvasive blood pressure measurement system. |
| MCKESSON CARDIOLOGY ECG MOBILE | MCKESSON ISRAEL LTD | K133534 | 2014/04/18 | DQK | Computer, diagnostic, programmable | 870.1425 | Programmable diagnostic computer. |
| MCKESSON RADIOLOGY | MCKESSON MEDICAL IMAGING COMPANY | K140909 | 2014/07/02 | LLZ | System, image processing, radiological | 892.2050 | Picture archiving and communications system. |
| MEDAPPS REMOTE PATIENT MONITORING, MODEL MA 100 | MEDAPPS, INC. | K062377 | 2007/07/03 | NBW | system, test, blood glucose, over the counter | 862.1345 | Glucose test system. |
| MEDICALGORITHMICS REAL-TIME ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL POCKETECG | MEDICALGORITHMICS SP Z.O.O. | K090037 | 2009/05/22 | DSI | detector and alarm, arrhythmia | 870.1025 | Arrhythmia detector and alarm (including ST-segment measurement and alarm). |
| MOBILE MIM | MIM SOFTWARE INC. | K103785 | 2011/02/04 | LLZ | System, image processing, radiological | 892.2050 | Picture archiving and communications system. |
| MOBILE MIM | MIM SOFTWARE INC. | K112930 | 2011/12/02 | LLZ | System, image processing, radiological | 892.2050 | Picture archiving and communications system. |
| MOBILECT VIEWER | NEPHOSITY, INC. | K123082 | 2013/05/16 | LLZ | System, image processing, radiological | 892.2050 | Picture archiving and communications system. |
| MOBILE-PATIENT VIEWER | DATA CRITICAL CORPORATION | K011436 | 2001/07/05 | DPS | electrocardiograph | 870.2340 | Electrocardiograph. |
| MOBILE-PATIENT VIEWER | DATA CRITICAL CORPORATION | K011436 | 2001/07/05 | DPS | electrocardiograph | 870.2340 | Electrocardiograph. |
| MOBIUS ULTRASOUND IMAGING SYSTEM | MOBISANTE, INC. | K102153 | 2011/01/20 | IYO | system, imaging, pulsed echo, ultrasonic | 892.1560 | Ultrasonic pulsed echo imaging system. |
| MODIFICATION TO: CG-6108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL FG-00084 | CARD GUARD SCIENTIFIC SURVIVAL, LTD. | K101703 | 2010/07/13 | DSI | detector and alarm, arrhythmia | 870.1025 | Arrhythmia detector and alarm (including ST-segment measurement and alarm). |
| MODIFICATION TO: POCKETVIEW ECG SOFTWARE | MICROMEDICAL INDUSTRIES, LTD. | K013311 | 2002/01/03 | MHX | monitor, physiological, patient(with arrhythmia detection or alarms) | 870.1025 | Arrhythmia detector and alarm (including ST-segment measurement and alarm). |
| MODIFICATION TO: POCKETVIEW ECG SOFTWARE | MICROMEDICAL INDUSTRIES, LTD. | K013311 | 2002/01/03 | MHX | monitor, physiological, patient(with arrhythmia detection or alarms) | 870.1025 | Arrhythmia detector and alarm (including ST-segment measurement and alarm). |
| MOME ECG CONTINUOUS DETECTION AND ARRHYTHMIA DETECTOR | INFOBIONIC, INC. | K133753 | 2014/09/19 | DSI | Detector and alarm, arrhythmia | 870.1025 | Arrhythmia detector and alarm (including ST-segment measurement and alarm). |
| MYGLUCOHEALTH GLUCOSE MONITORING SYSTEMS | ENTRA HEALTH SYSTEMS, LTD. | K081703 | 2009/01/08 | NBW | system, test, blood glucose, over the counter | 862.1345 | Glucose test system. |
| MYHEALTHPOINT TELEHEALTH MANAGER | ENTRA HEALTH SYSTEMS | K132930 | 2014/04/14 | DRG | Transmitters and receivers, physiological signal, radiofrequency | 870.2910 | Radiofrequency physiological signal transmitter and receiver. |
| MYVISIONTRACK(TM) | VITAL ART AND SCIENCE INCORPORATED | K121738 | 2013/02/22 | HPT | perimeter, automatic, ac-powered | 886.1605 | Perimeter. |
| NUVIS DIAGNOSTIC ULTRASOUND SYSTEM | PHILIPS HEALTHCARE INC. | K133833 | 2014/01/17 | IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 892.1550 | Ultrasonic pulsed doppler imaging system. |
| ORTHOSIZE | ORTHOSIZE LLC | K120115 | 2012/03/14 | LLZ | System, image processing, radiological | 892.2050 | Picture archiving and communications system. |
| OSTOM-I ALERT | 11 HEALTH AND TECHNOLOGIES LLC | K140938 | 2014/10/10 | EXB | collector, ostomy | 876.5900 | Ostomy pouch and accessories. |
| PANOPTIC | WELCH ALLYN, INC. | K121405 | 2012/12/20 | HKI | camera, ophthalmic, ac-powered | 886.1120 | Ophthalmic camera. |
| PHYSIOGLOVE ET SYSTEM | COMMWELL LTD. | K133703 | 2014/08/18 | DXH | Transmitters and receivers, electrocardiograph, telephone | 870.2920 | Telephone electrocardiograph transmitter and receiver. |
| PILL PHONE | VOCEL | K060298 | 2006/03/29 | NXQ | reminder, medication | 890.5050 | Daily activity assist device. |
| PIXEL APP | GAUSS SURGICAL, INC. | K120473 | 2012/04/09 | LWH | counter, sponge, surgical | 880.2740 | Surgical sponge scale. |
| PIXEL APP | GAUSS SURGICAL, INC. | K121274 | 2012/06/27 | LWH | counter, sponge, surgical | 880.2740 | Surgical sponge scale. |
| PROPELLER SYSTEM - MODEL 2 | RECIPROCAL LABS CORPORATION | K140638 | 2014/05/02 | CAF | nebulizer (direct patient interface) | 868.5630 | Nebulizer. |
| QARDIOARM | QARDIO, INC | K140067 | 2014/06/18 | DXN | System, measurement, blood-pressure, non-invasive | 870.1130 | Noninvasive blood pressure measurement system. |
| RAPIDRESULTS | RAMSOFT, INC. | K141881 | 2014/10/31 | LLZ | System, image processing, radiological | 892.2050 | Picture archiving and communications system. |
| REKA E100 | REKA PTE LTD | K111438 | 2011/09/12 | DPS | electrocardiograph | 870.2340 | Electrocardiograph. |
| RESOLUTIONMD MOBILE | CALGARY SCIENTIFIC INC. | K133508 | 2014/03/26 | LLZ | System, image processing, radiological | 892.2050 | Picture archiving and communications system. |
| RESOLUTIONMD MOBILE 3.1 MODEL RMD-MOB-31 | CALGARY SCIENTIFIC, INC. | K123186 | 2013/03/14 | LLZ | System, image processing, radiological | 892.2050 | Picture archiving and communications system. |
| RESOLUTIONMD MOBILE MODEL RMB-MOB-2X | CALGARY SCIENTIFIC, INC. | K111346 | 2011/09/09 | LLZ | System, image processing, radiological | 892.2050 | Picture archiving and communications system. |
| RHYTHMSTAT XL | DATA CRITICAL CORP. | K971650 | 1997/12/04 | DXH | transmitters and receivers, electrocardiograph, telephone | 870.2920 | Telephone electrocardiograph transmitter and receiver. |
| SD360 DIGITAL RECORDER/SD360 HOLTER DIGITAL RECORDER | NORTHEAST MONITORING, INC. | K041901 | 2004/08/31 | MWJ | electrocardiograph,ambulatory(without analysis) | 870.2800 | Medical magnetic tape recorder. |
| SILHOUETTE, MODEL 1000.01 | ARANZ MEDICAL LIMITED | K070426 | 2007/06/29 | FXN | tape, camera, surgical | 878.4160 | Surgical camera and accessories. |
| SMARTHEART | SHL TELEMEDICINE INTERNATIONAL LTD. | K113514 | 2012/02/22 | DXH | Transmitters and receivers, electrocardiograph, telephone | 870.2920 | Telephone electrocardiograph transmitter and receiver. |
| Smith & Nephew, Inc. Spatialframe.com V5.0 Web-based software | SMITH & NEPHEW, INC. | K142520 | 2014/11/20 | KTT | appliance, fixation, nail/blade/plate combination, multiple component | 888.3030 | Single/multiple component metallic bone fixation appliances and accessories. |
| SPECTRUM AND SPECTRUM WITH MASTER DRUG LIBRARY | SIGMA INTL. | K042121 | 2004/08/26 | FRN | pump, infusion | 880.5725 | Infusion pump. |
| SURGICASE CONNECT | MATERIALISE N.V. | K113599 | 2012/04/27 | LLZ | System, image processing, radiological | 892.2050 | Picture archiving and communications system. |
| SYMCARE DIABETES MANAGEMENT PROGRAM | SYMCARE PERSONALIZED HEALTH SOLUTIONS, INC | K083263 | 2009/03/13 | NBW | system, test, blood glucose, over the counter | 862.1345 | Glucose test system. |
| SYNGO.VIA WEB VIEWER | SIEMENS AG, MEDICAL SOLUTIONS | K130998 | 2014/01/03 | LLZ | System, image processing, radiological | 892.2050 | Picture archiving and communications system. |
| TABLET VIEWER SOFTWARE FOR IMAGE SUITE | CARESTREAM HEALTH INC. | K140271 | 2014/04/01 | LLZ | System, image processing, radiological | 892.2050 | Picture archiving and communications system. |
| TM2005 PERSONAL MEDICAL PHONE CENTER | CARD GUARD SCIENTIFIC SURVIVAL, LTD. | K024365 | 2003/01/15 | DXH | transmitters and receivers, electrocardiograph, telephone | 870.2920 | Telephone electrocardiograph transmitter and receiver. |
| VEO MULTIGAS MONITOR FOR POCKET PC, MODEL 400221 | WEISSBURG ASSOCIATES | K051857 | 2005/09/15 | CCK | analyzer, gas, carbon-dioxide, gaseous-phase | 868.1400 | Carbon dioxide gas analyzer. |
| VESTIBULAR ANALYSIS APPARATUS | CAPACITY SPORTS, LLC | K121590 | 2012/09/20 | LXV | apparatus, vestibular analysis | Pre-Amendment | |
| VITAL SIGNS PATCH SYSTEM (IN SHORT "VSP") | LIFEWATCH TECHNOLOGIES LTD. | K132407 | 2014/12/19 | DSI | detector and alarm, arrhythmia | 870.1025 | Arrhythmia detector and alarm (including ST-segment measurement and alarm). |
| WAVESENSE DIABETES MANAGER MODEL VERSION 1.3.4 | AGAMATRIX | K101597 | 2010/10/18 | NBW | system, test, blood glucose, over the counter | 862.1345 | Glucose test system. |
| WEB VIEWER, POCKET VIEWER AND CELLULAR VIEWER WITH L- WEB05 SOFTWARE | GE HEALTHCARE | K061994 | 2006/08/11 | MSX | system,network and communication,physiological monitors | 870.2300 | Cardiac monitor (including cardiotachometer and rate alarm). |
| WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM | WELLDOC, INC | K112370 | 2011/10/14 | MRZ | accessories, pump, infusion | 880.5725 | Infusion pump. |
| WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM | WELLDOC, INC | K120314 | 2012/02/24 | MRZ | accessories, pump, infusion | 880.5725 | Infusion pump. |
| WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER- RX SYSTEM | WELLDOC INC. | K141273 | 2014/07/08 | EXB | collector, ostomy | 876.5900 | Ostomy pouch and accessories. |
| WITHINGS BLOOD PRESSURE MONITOR | WITHINGS | K110872 | 2011/05/20 | DXN | system, measurement, blood-pressure, non-invasive | 870.1130 | Noninvasive blood pressure measurement system. |
| WITHINGS BLOOD PRESURE MONITOR | WITHINGS | K133125 | 2014/03/24 | DXN | System, measurement, blood-pressure, non-invasive | 870.1130 | Noninvasive blood pressure measurement system. |
| WITHINGS, SMART BODY SCALE | ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD. | K121971 | 2012/09/27 | MNW | analyzer, body composition | 870.2770 | Impedance plethysmograph. |
| Z1 CPAP SYSTEM | HUMAN DESIGN MEDICAL, LLC | K140929 | 2014/10/17 | BZD | ventilator, non-continuous (respirator) | 868.5905 | Noncontinuous ventilator (IPPB). |
| ZOLL CODE WRITER | ZOLL MEDICAL CORPORATION | K132488 | 2014/04/03 | DXJ | Display, cathode-ray tube, medical | 870.2450 | Medical cathode-ray tube display. |
| ZOLL X SERIES | ZOLL MEDICAL CORPORATION | K141774 | 2014/11/19 | MKJ | automated external defibrillators (non-wearable) | 870.5310 | Automated external defibrillator system. |