510(k) K243324 ยท MUD Oximeter, Tissue Saturation
Masimo O3 Regional Oximeter
| Applicant | Masimo Corporation, Irvine CA, US |
| Decision | Substantially Equivalent, Jul 17, 2025 |
| Received | Oct 23, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243324
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.