ClearanceBrief
510(k) K043454 ยท MLO Electrocardiograph, Ambulatory, With Analysis Algorithm

CARDIOPAL AI WITH DIOGENES SV (CARDIOPAL SV), MODEL PM410

ApplicantMedicomp, Inc., Great Neck NY, US
DecisionSubstantially Equivalent, Mar 24, 2005
ReceivedDec 15, 2004
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K043454

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.