Medical Device Manufacturer · US , Echo , OR

Samsung Electronics Co., Ltd. - FDA 510(k) Cleared Devices

40 submissions · 39 cleared · Since 2013

40

Total

39

Cleared

1

Denied

FDA 510(k) cleared devices by Samsung Electronics Co., Ltd. Cardiovascular ✕

4 devices

1-4 of 4

Cleared Aug 02, 2024

Samsung ECG App v 1.3 (ECG)

Cardiovascular · 122d

Cleared May 02, 2023

Samsung ECG Monitor Application with Irregular Heart Rhythm Notification

Cardiovascular · 89d

Cleared Aug 04, 2020

ECG Monitor App

Cardiovascular · 95d

Cleared Dec 04, 2013

Cardiovascular · 146d