ClearanceBrief
510(k) K970585 ยท DSI Detector And Alarm, Arrhythmia

FUKUDA DENSHI DYNASCOPE MODEL DS-5800 CENTRAL STATION MONITOR

ApplicantFukuda Denshi USA, Inc., Redmond WA, US
DecisionSubstantially Equivalent, Sep 9, 1997
ReceivedFeb 14, 1997
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K970585

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.