An official website of the United States government Here’s how you know

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

In this section: Substantially Equivalent 510(k) Device Information

BK190333 - Terumo Operational Medical Equipment Software (TOMEs), Version 7.1

510(k) Number: BK190333
Applicant: Terumo BCT, Inc.
Device Name: Terumo Operational Medical Equipment Software (TOMEs), Version 7.1
Decision Date: 12/3/2019

Supporting Documents

BK190333 Letter
BK190333 Summary

Top