ClearanceBrief
510(k) K240795 ยท QDA Electrocardiograph Software For Over-The-Counter Use

Withings ECG App

ApplicantWithings, Issy-Les-Moulineaux, FR
DecisionSubstantially Equivalent, Jun 15, 2025
ReceivedMar 22, 2024
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K240795

No recall in the FDA data names this 510(k).

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.