510(k) K201446 ยท DQK Computer, Diagnostic, Programmable
HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module
| Applicant | Edwards Lifesiences, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, Oct 1, 2020 |
| Received | Jun 1, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201446
| 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.