510(k) K823904 ยท DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
MODEL 515 NEO-TRAK NEONATAL MONITOR
| Applicant | Ge Medical Systems Information Technologies, Walker MI, US |
| Decision | Substantially Equivalent, May 25, 1983 |
| Received | Dec 28, 1982 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K823904
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.