510(k) K812674 ยท DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
INFANT CARIDAC MONITOR
| Applicant | Electromed Intl., Ltd., Mchenry IL, US |
| Decision | Substantially Equivalent, Oct 13, 1981 |
| Received | Sep 22, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K812674
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.