510(k) K770038 ยท DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
MONITOR, HEARTWATCH HEART RATE
| Applicant | Respironics, Inc., Monroeville PA, US |
| Decision | Substantially Equivalent, Jan 14, 1977 |
| Received | Jan 10, 1977 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K770038
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.