510(k) K911598 ยท DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
DATASCOPE PASSPORT MONITOR
| Applicant | Datascope Corp., Paramus NJ, US |
| Decision | Substantially Equivalent, Oct 15, 1991 |
| Received | Apr 9, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K911598
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.