510(k) K974792 ยท DSI Detector And Alarm, Arrhythmia
CS/3(TM) MONITORS*
| Applicant | Datex-Engstrom, Inc., Tewksbury MA, US |
| Decision | Substantially Equivalent, Jun 2, 1998 |
| Received | Dec 22, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974792
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.