510(k) K253417 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Masimo Root Monitoring System
| Applicant | Masimo Corporation, Irvine CA, US |
| Decision | Substantially Equivalent, Aug 12, 2026 |
| Received | Oct 1, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253417
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.