510(k) K091050 ยท DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
506CN PATIENT MONITOR
| Applicant | Criticare Systems, Inc., Waukesha WI, US |
| Decision | Substantially Equivalent, May 27, 2009 |
| Received | Apr 13, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K091050
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.