510(k) K861621 ยท DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
CARDIAN II CR45A
| Applicant | Cardiac Recorders, Ltd., London, GB |
| Decision | Substantially Equivalent, Sep 12, 1986 |
| Received | Apr 29, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K861621
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.