ClearanceBrief
510(k) K071228 ยท DXH Transmitters And Receivers, Electrocardiograph, Telephone

FIDELITY 200 CARDIAC EVENT RECORDER

ApplicantSignalife, Inc., Greenville SC, US
DecisionSubstantially Equivalent, Nov 21, 2007
ReceivedMay 3, 2007
TypeAbbreviated
FDA recordOpen on fda.gov

Recalls that name K071228

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.