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

Name: FDA 510(k) clearance K230292
Creator: U.S. Food and Drug Administration
Published: 2023-05-02

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.. 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: 2023-02-02
Decision date: 2023-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suwon-Si, KR

Download summary PDF View on FDA.gov ↗

Recent devices under product code QDA

view all

K240795 — Withings ECG App2025-06-15
K243236 — WHOOP ECG (electrocardiogram) Feature (1.0)2025-04-04
K240909 — Samsung ECG App v 1.3 (ECG)2024-08-02
K221774 — Garmin ECG App2023-01-12
K201525 — ECG App2020-10-08

More clearances from Samsung Electronics Co., Ltd.

view all

K260481 — GC85A2026-08-27
K261187 — Hearing Aid Feature2026-07-31
K261011 — Sleep Apnea Feature (v2.0)2026-07-20
K242651 — GM852024-10-01
K242478 — GF85 (models GF85-3P, GF85-SP)2024-09-19

Data sourced from openFDA. This site is unofficial and independent of the FDA.