510(k) K180003 ยท MUD Oximeter, Tissue Saturation
FORE-SIGHT ELITE Module Tissue Oximeter
| Applicant | Cas Medical Systems, Inc., Branford CT, US |
| Decision | Substantially Equivalent, May 10, 2018 |
| Received | Jan 2, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180003
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 1, 2022 | Edwards Lifesciences, LLC FORE-SIGHT ELITE Tissue Oximeter module, REF: HEMFSM10 Open, Classified |
MUD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.