510(k) K854847 ยท DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
PHYSIO-DYNE ECG/HR 3
| Applicant | Physio-Dyne Industrument Corp., Massapequa NY, US |
| Decision | Substantially Equivalent, Jun 16, 1986 |
| Received | Dec 4, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K854847
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.