ClearanceBrief
510(k) DEN180044 ยท QDA Electrocardiograph Software For Over-The-Counter Use

ECG App

ApplicantApple, Inc., Alexandria VA, US
DecisionUnknown, Sep 11, 2018
ReceivedAug 14, 2018
TypeDirect
FDA recordOpen on fda.gov

Recalls that name DEN180044

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.