510(k) K162603 ยท MUD Oximeter, Tissue Saturation
Masimo O3 Regional Oximeter System
| Applicant | Masimo Corporation, Irvine CA, US |
| Decision | Substantially Equivalent, May 26, 2017 |
| Received | Sep 19, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162603
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.