510(k) K260438 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Vital Signs Monitor (CLEO2)
| Applicant | Infinium Medical, Inc., Largo FL, US |
| Decision | Substantially Equivalent, Aug 14, 2026 |
| Received | Feb 11, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260438
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.