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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 K201525
Device Name ECG App
Apple Inc.
One Apple Park Way
Cupertino,  CA  94015
Applicant Contact Luke Olson
Apple Inc.
One Apple Park Way
Cupertino,  CA  94015
Correspondent Contact Luke Olson
Regulation Number870.2345
Classification Product Code
Date Received06/08/2020
Decision Date 10/08/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No