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

Name: FDA 510(k) clearance K240909
Creator: U.S. Food and Drug Administration
Published: 2024-08-02

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.. Device class: 2.

Clearance details

Applicant: Samsung Electronics Co., Ltd.
Product code: Code QDA
Device class: Class 2
Regulation: 21 CFR 870.2345
Advisory panel: Cardiovascular
Date received: 2024-04-02
Decision date: 2024-08-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suwon-Si, KR

Download summary PDF View on FDA.gov ↗

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K221774 — Garmin ECG App2023-01-12
K201525 — ECG App2020-10-08

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