510(k) K897063 ยท DSI Detector And Alarm, Arrhythmia
FUKUDA DENSHI MODEL DS-3300 ETR
| Applicant | Fukuda Denshi USA, Inc., Redmond WA, US |
| Decision | Substantially Equivalent, Feb 1, 1990 |
| Received | Dec 20, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K897063
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.