510(k) K203490 ยท MUD Oximeter, Tissue Saturation
FORE-SIGHT ELITE Absolute Tissue Oximeter
| Applicant | Edwards Lifesciences, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, Feb 10, 2021 |
| Received | Nov 27, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203490
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 1, 2022 | Edwards Lifesciences, LLC FORE-SIGHT ELITE Absolute Tissue Oximeter, REF: 01-06-3000, Contents: Monitor 1 EA., Accessory Kit 1 EA. Open, Classified |
MUD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.