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  1. Substantially Equivalent 510(k) Device Information

BK180200: LifeTrak 2018

510(k) number: BK180200
Applicant: Mediware Information Systems, Inc.
Device Name: LifeTrak®2018
Decision Date: 7/3/2018

Supporting Documents

  • BK180200 Letter
    The original posted letter has been replaced with a revised letter to add the regulation name and CFR, and to change the dated/received dates.
  • BK180200 Summary
    The original posted summary has been replaced with a revised summary to update the Classification name.
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