510(k) K934644 ยท DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
K3 SYSTEM
| Applicant | Astro-Med, Inc., West Warwick RI, US |
| Decision | Substantially Equivalent, Nov 1, 1994 |
| Received | Sep 29, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K934644
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.