ClearanceBrief
510(k) K113514 ยท DXH Transmitters And Receivers, Electrocardiograph, Telephone

SMARTHEART

ApplicantShl Telemedicine International , Ltd., Binyamina, IL
DecisionSubstantially Equivalent, Feb 22, 2012
ReceivedNov 28, 2011
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K113514

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.