510(k) K223651 ยท MUD Oximeter, Tissue Saturation
Cerebral Adaptive Index (CAI) Algorithm
| Applicant | Edwards Lifesciences, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, May 26, 2023 |
| Received | Dec 6, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K223651
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.