510(k) K853953 ยท DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
CARDIOCAP MONITOR
| Applicant | Instrumentarium Corp., Wilmington MA, US |
| Decision | Substantially Equivalent, Jun 2, 1986 |
| Received | Sep 25, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K853953
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.