Withings ECG App— 510(k) K240795

Substantially Equivalent

Withings

FDA 510(k) clearance K240795 for Withings ECG App, Substantially Equivalent on 2025-06-15. Applicant: Withings. Device class: 2.

Clearance details

Applicant: Withings
Product code: Code QDA
Device class: Class 2
Regulation: 21 CFR 870.2345
Advisory panel: Cardiovascular
Date received: 2024-03-22
Decision date: 2025-06-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Issy-Les-Moulineaux, FR

Download summary PDF View on FDA.gov ↗

Recent devices under product code QDA

K243236 — WHOOP ECG (electrocardiogram) Feature (1.0)2025-04-04
K240909 — Samsung ECG App v 1.3 (ECG)2024-08-02
K230292 — Samsung ECG Monitor Application with Irregular Heart Rhythm Notification2023-05-02
K221774 — Garmin ECG App2023-01-12
K201525 — ECG App2020-10-08

More clearances from Withings

K252474 — Withings BeamO (SCT02)2025-11-10
K231667 — Withings Sleep Rx2024-09-06
K230812 — Withings Scan Monitor 2.02023-08-23
K160544 — Withings Thermo (Model SCT01)2016-06-17
K133125 — WITHINGS BLOOD PRESURE MONITOR2014-03-24

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