510(k) K854639 ยท DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
BIOMECCA CENTRAL CS1
| Applicant | Biomecca Australia , Ltd., Washington DC, US |
| Decision | Substantially Equivalent, Apr 17, 1986 |
| Received | Nov 19, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K854639
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.