510(k) K820540 ยท DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
OLLI 565
| Applicant | Kone Instruments, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Apr 1, 1982 |
| Received | Mar 2, 1982 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K820540
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.