510(k) K974747 ยท DSI Detector And Alarm, Arrhythmia
CS/3 ARRHYTHMIA WORKSTATION
| Applicant | Datex-Engstrom, Inc., Tewksbury MA, US |
| Decision | Substantially Equivalent, Apr 23, 1998 |
| Received | Dec 19, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974747
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.