510(k) K223127 ยท DQK Computer, Diagnostic, Programmable
HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable
| Applicant | Edwards Lifeciences, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, Nov 7, 2022 |
| Received | Oct 3, 2022 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K223127
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.