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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
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