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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name photoplethysmograph analysis software for over-the-counter use
510(k) Number K213971
Device Name Atrial Fibrillation History Feature
Apple Inc.
1 Apple Park Way
Cupertino,  CA  95014
Applicant Contact Luke Olson
Apple Inc.
1 Apple Park Way
Cupertino,  CA  95014
Correspondent Contact Luke Olson
Regulation Number870.2790
Classification Product Code
Date Received12/20/2021
Decision Date 06/03/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No