510(k) K240596 ยท MUD Oximeter, Tissue Saturation
Cerebral Autoregulation Index (CAI) Algorithm
| Applicant | Edwards Lifesciences, Irvine CA, US |
| Decision | Substantially Equivalent, Oct 16, 2024 |
| Received | Mar 4, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K240596
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.