510(k) K974178 ยท DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
PASSPORT 5L-CE MODEL 0998-00-0131XXX
| Applicant | Datascope Corp., Paramus NJ, US |
| Decision | Substantially Equivalent, Jun 26, 1998 |
| Received | Nov 6, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974178
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.