ClearanceBrief
510(k) K121628 ยท DXH Transmitters And Receivers, Electrocardiograph, Telephone

EPI MINI ECG PORTABLE HEALTH MONITORING SYSTEM (EPI MINI)

ApplicantEpi Mobile Health Solutions (S) Pte, Ltd., Washington DC, US
DecisionSubstantially Equivalent, Jun 25, 2013
ReceivedJun 4, 2012
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K121628

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.