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FDA 510(k) Applications for Medical Device Product Code "QDB"
FDA 510(k) Number
Applicant
Device Name
Decision Date
DEN180042
Apple Inc
Irregular Rhythm Notification Feature
09/11/2018
K213971
Apple Inc.
Atrial Fibrillation History Feature
06/03/2022
K212516
Apple Inc.
IRNF App
10/22/2021
K231173
Apple Inc.
Irregular Rhythm Notification Feature (IRNF)
07/21/2023
K212372
Fitbit Inc
Fitbit Irregular Rhythm Notifications
04/08/2022
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