510(k) K971131 ยท DSI Detector And Alarm, Arrhythmia
FUKUDA DENSHI MODEL DS-5100E PORTABLE PATIENT MONITOR
| Applicant | Fukuda Denshi USA, Inc., Redmond WA, US |
| Decision | Substantially Equivalent, Oct 3, 1997 |
| Received | Mar 27, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971131
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.