ECG Monitor App— 510(k) K201168

Substantially Equivalent

Samsung Electronics Co., Ltd.

FDA 510(k) clearance K201168 for ECG Monitor App, Substantially Equivalent on 2020-08-04. Applicant: Samsung Electronics Co., Ltd..

Clearance details

Applicant: Samsung Electronics Co., Ltd.
Product code: Code QDA
Advisory panel: Cardiovascular
Date received: 2020-05-01
Decision date: 2020-08-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suwon-Si, KR

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