510(k) K812828 ยท DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
MODEL 2000 MONITOR
| Applicant | Datascope Corp., Mchenry IL, US |
| Decision | Substantially Equivalent, Nov 16, 1981 |
| Received | Oct 8, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K812828
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.