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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 K212516
Device Name IRNF App
Applicant
Apple, Inc.
1 Apple Park Way
Cupertino,  CA  95014
Applicant Contact Dachan Kwon
Correspondent
Apple, Inc.
1 Apple Park Way
Cupertino,  CA  95014
Correspondent Contact Luke Olson
Regulation Number870.2790
Classification Product Code
QDB  
Date Received08/10/2021
Decision Date 10/22/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT04699812
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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