ClearanceBrief
510(k) K000638 ยท MKJ Automated External Defibrillators (Non-Wearable)

RESPONDER 3000

ApplicantGe Medical Systems Information Technologies GmbH, Freiburg, DE
DecisionSubstantially Equivalent, Oct 30, 2000
ReceivedFeb 25, 2000
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K000638

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.