ClearanceBrief
510(k) K965158 ยท DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)

HEART PROTECTOR (VER 1996)

ApplicantN.P.N.T., Inc., Downsview, Ontario, CA
DecisionSubstantially Equivalent, Dec 9, 1997
ReceivedDec 23, 1996
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K965158

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.