510(k) K103268 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
OMNI EXPRESS
| Applicant | Infinium Medical, Appollo Beach FL, US |
| Decision | Substantially Equivalent, Nov 23, 2010 |
| Received | Nov 4, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K103268
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.