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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 K231173
Device Name Irregular Rhythm Notification Feature (IRNF)
Apple Inc.
One Apple Park Way
Cupertino,  CA  95014
Applicant Contact Bonnie Wu
Apple Inc.
One Apple Park Way
Cupertino,  CA  95014
Correspondent Contact Bonnie Wu
Regulation Number870.2790
Classification Product Code
Date Received04/25/2023
Decision Date 07/21/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No