510(k) K811425 ยท DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
CARDIACMONITORS
| Applicant | Pulse Time Products, Ltd., Walker MI, US |
| Decision | Substantially Equivalent, Sep 16, 1981 |
| Received | May 22, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K811425
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.