510(k) K250135 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
WAVE Clinical Platform (2.0.000)
| Applicant | Baxter Healthcare Corp/ Excel Medical, Palm Beach Gardens FL, US |
| Decision | Substantially Equivalent, Jan 16, 2026 |
| Received | Jan 17, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250135
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.