510(k) K894628 ยท DSI Detector And Alarm, Arrhythmia
MODEL DS-3300 DYNASCOPE PATIENT MONITOR
| Applicant | Fukuda Denshi USA, Inc., Redmond WA, US |
| Decision | Substantially Equivalent, Jan 8, 1990 |
| Received | Jul 24, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K894628
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.