510(k) K231038 ยท QNL Medium-Term Adjunctive Predictive Cardiovascular Indicator
Global Hypoperfusion Index (GHI) Algorithm
| Applicant | Edwards Lifesciences, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, Jul 26, 2023 |
| Received | Apr 12, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231038
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.