510(k) Report

Devices descending from DEN180042

7 later devices reach Irregular Rhythm Notification Feature through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230292Samsung ECG Monitor Application with Irregular Heart Rhythm NotificationSamsung Electronics Co., Ltd.20231—
+1K212372Fitbit Irregular Rhythm NotificationsFitbit, Inc.20221—
+1K212516IRNF AppApple, Inc.20212—
+2K242967Loss of Pulse DetectionFitbit20250—
+2K240909Samsung ECG App v 1.3 (ECG)Samsung Electronics Co., Ltd.20240—
+2K231173Irregular Rhythm Notification Feature (IRNF)Apple, Inc.20230—
+2K213971Atrial Fibrillation History FeatureApple, Inc.20220—