510(k) DEN160044 ยท QAQ Adjunctive Predictive Cardiovascular Indicator
Acumen Hypotension Prediction Index (HPI) Feature Software
| Applicant | Edwards Lifesciences, LLC, Irvine CA, US |
| Decision | Unknown, Mar 16, 2018 |
| Received | Sep 26, 2016 |
| Type | Direct |
| FDA record | Open on fda.gov |
Recalls that name DEN160044
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.