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FDA 510(k) Applications for Medical Device Product Code "QDA"
FDA 510(k) Number
Applicant
Device Name
Decision Date
DEN180044
Apple Inc
ECG App
09/11/2018
K201525
Apple Inc.
ECG App
10/08/2020
K200948
Fitbit, Inc.
Fitbit ECG App
09/11/2020
K221774
Garmin International, Inc.
Garmin ECG App
01/12/2023
K201168
Samsung Electronics Co., Ltd
ECG Monitor App
08/04/2020
K230292
Samsung Electronics Co., Ltd
Samsung ECG Monitor Application with Irregular Heart Rhythm Notification
05/02/2023
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