510(k) K112329 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
OMNI PATIENT MONITOR
| Applicant | Infinium Medical, Appollo Beach FL, US |
| Decision | Substantially Equivalent, Sep 8, 2011 |
| Received | Aug 12, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K112329
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.