510(k) K782089 ยท DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
MONITOR, HEART RATE MODEL 103
| Applicant | Roche Medical Electronics, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Jan 4, 1979 |
| Received | Dec 14, 1978 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K782089
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.