510(k) K851335 ยท DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
COACH TM- THE AEROBIC FITNESS MONITOR
| Applicant | Biotechnology, Inc., Miami FL, US |
| Decision | Substantially Equivalent, Jul 24, 1985 |
| Received | Apr 3, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K851335
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.