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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name electrocardiograph software for over-the-counter use
510(k) Number K200948
Device Name Fitbit ECG App
Fitbit, Inc.
199 Fremont Street
San Francisco,  CA  94105
Applicant Contact Shruti Rajagopalan
Fitbit, Inc.
199 Fremont Street
San Francisco,  CA  94105
Correspondent Contact Shruti Rajagopalan
Regulation Number870.2345
Classification Product Code
Date Received04/08/2020
Decision Date 09/11/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT04176926
Reviewed by Third Party No
Combination Product No