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.

Clearance details

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

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