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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
Apple Inc.
1 Apple Park Way
cupertino,  CA  95014
Applicant Contact dachan kwon
Apple Inc.
1 Apple Park Way
cupertino,  CA  95014
Correspondent Contact luke olson
Regulation Number870.2790
Classification Product Code
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