510(k) K964187 ยท DSI Detector And Alarm, Arrhythmia
FUKADA DENSHI DYNASCOPE MODEL DS-5300 PATIENT MONITOR
| Applicant | Fukuda Denshi USA, Inc., Great Neck, NY, US |
| Decision | Substantially Equivalent, May 1, 1997 |
| Received | Oct 21, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964187
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.