510(k) K854198 ยท DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
PE-3000 PULSE RATE MONITOR
| Applicant | Quantum Life Systems, Inc., Great Meadows NJ, US |
| Decision | Substantially Equivalent, Mar 13, 1986 |
| Received | Oct 15, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K854198
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.