510(k) K230612 ยท MUD Oximeter, Tissue Saturation
Edwards Algorithm for Measurement of Blood Hemoglobin
| Applicant | Edwards Lifesciences, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, Nov 17, 2023 |
| Received | Mar 6, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230612
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.