Samsung ECG App v 1.3 (ECG)— 510(k) K240909

Substantially Equivalent

Samsung Electronics Co., Ltd.

FDA 510(k) clearance K240909 for Samsung ECG App v 1.3 (ECG), Substantially Equivalent on 2024-08-02. Applicant: Samsung Electronics Co., Ltd..

Clearance details

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