510(k) K203224 ยท QAQ Adjunctive Predictive Cardiovascular Indicator
Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform
| Applicant | Edwards Lifesciences, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, Jul 30, 2021 |
| Received | Nov 2, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203224
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.