510(k) K850407 ยท DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
NEONATAL MONITOR 309
| Applicant | Rigel Medical Electronics, Inc., Mill Valley CA, US |
| Decision | Substantially Equivalent, Apr 18, 1985 |
| Received | Feb 4, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K850407
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.