ClearanceBrief
510(k) K213971 ยท QDB Photoplethysmograph Analysis Software For Over-The-Counter Use

Atrial Fibrillation History Feature

ApplicantApple, Inc., Cupertino CA, US
DecisionSubstantially Equivalent, Jun 3, 2022
ReceivedDec 20, 2021
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K213971

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.