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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
Applicant
Apple Inc.
1 Apple Park Way
Cupertino,  CA  95014
Applicant Contact Luke Olson
Correspondent
Apple Inc.
1 Apple Park Way
Cupertino,  CA  95014
Correspondent Contact Luke Olson
Regulation Number870.2790
Classification Product Code
QDB  
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
Predetermined Change
Control Plan Authorized		 No
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