Samsung ECG Monitor Application with Irregular Heart Rhythm Notification— 510(k) K230292

Substantially Equivalent

Samsung Electronics Co., Ltd.

FDA 510(k) clearance K230292 for Samsung ECG Monitor Application with Irregular Heart Rhythm Notification, Substantially Equivalent on 2023-05-02. Applicant: Samsung Electronics Co., Ltd..

Clearance details

Applicant: Samsung Electronics Co., Ltd.
Product code: Code QDA
Advisory panel: Cardiovascular
Date received: 2023-02-02
Decision date: 2023-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suwon-Si, KR

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