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FDA 510(k) Applications Submitted by Apple Inc.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K231173
04/25/2023
Irregular Rhythm Notification Feature (IRNF)
Apple Inc.
K212516
08/10/2021
IRNF App
Apple Inc.
K201525
06/08/2020
ECG App
Apple Inc.
K213971
12/20/2021
Atrial Fibrillation History Feature
Apple Inc.
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