ClearanceBrief
510(k) K882168 ยท DRO Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)

EXTERNAL PACEMAKER 2000 (EP2000)

ApplicantUnomed, Inc., Ft. Myers FL, US
DecisionSubstantially Equivalent, Aug 19, 1988
ReceivedMay 24, 1988
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K882168

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.