ClearanceBrief
510(k) K123916 ยท DTE Pulse-Generator, Pacemaker, External

PSA SERIES

ApplicantOsypka Medical, Inc., La Jolla CA, US
DecisionUnknown, Apr 9, 2013
ReceivedDec 19, 2012
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K123916

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.