510(k) K970585 ยท DSI Detector And Alarm, Arrhythmia
FUKUDA DENSHI DYNASCOPE MODEL DS-5800 CENTRAL STATION MONITOR
| Applicant | Fukuda Denshi USA, Inc., Redmond WA, US |
| Decision | Substantially Equivalent, Sep 9, 1997 |
| Received | Feb 14, 1997 |
| Type | Traditional |
| FDA record | Open 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.