510(k) K801515 ยท DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
ABBY II PATIENT MONITOR OR VITAL SIGNS M
| Applicant | Abbott Medical Electronics Co., Fort Worth TX, US |
| Decision | Substantially Equivalent, Jul 8, 1980 |
| Received | Jun 30, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K801515
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.