510(k) K101052 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
OMNI III PATIENT MONITOR
| Applicant | Infinium Medical, Appollo Beach FL, US |
| Decision | Substantially Equivalent, Aug 11, 2010 |
| Received | Apr 15, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101052
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.