510(k) K132229 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
OMNI PATENT MONITORS
| Applicant | Infinium Medical, Apollo Beach FL, US |
| Decision | Substantially Equivalent, Feb 21, 2014 |
| Received | Jul 18, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132229
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.