510(k) K911611 ยท DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
SYSTEM ATHENA, MODIFICATION
| Applicant | S & W Medico Teknik, Denmark, DK |
| Decision | Substantially Equivalent, Feb 5, 1993 |
| Received | Apr 9, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K911611
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.