510(k) K022435 ยท DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
507EL VITAL SIGNS MONITOR
| Applicant | Criticare Systems, Inc., Waukesha WI, US |
| Decision | Substantially Equivalent, Aug 14, 2002 |
| Received | Jul 25, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K022435
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.