510(k) K110429 ยท DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
PROSIM 4, PROSIM 6, PROSIM 8
| Applicant | Fluke Biomedical, Cleveland OH, US |
| Decision | Substantially Equivalent, Sep 2, 2011 |
| Received | Feb 15, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110429
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.