ClearanceBrief
510(k) K240909 ยท QDA Electrocardiograph Software For Over-The-Counter Use

Samsung ECG App v 1.3 (ECG)

ApplicantSamsung Electronics Co., Ltd., Suwon-Si, KR
DecisionSubstantially Equivalent, Aug 2, 2024
ReceivedApr 2, 2024
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K240909

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.