510(k) K012059 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
8100/8500 VITAL SIGNS MONITOR
| Applicant | Criticare Systems, Inc., Waukesha WI, US |
| Decision | Substantially Equivalent, Aug 1, 2001 |
| Received | Jul 2, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K012059
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.