510(k) K143675 ยท MUD Oximeter, Tissue Saturation
FORE-SIGHT Elite Absolute Tissue Oximeter
| Applicant | Cas Medical Systems, Inc., Branford CT, US |
| Decision | Substantially Equivalent, Apr 10, 2015 |
| Received | Dec 24, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143675
| 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.