The following data is part of a De Novo classification by Edwards Lifesciences Llc with the FDA for Acumen Hypotension Prediction Index (hpi) Feature Software.
| DeNovo ID | DEN160044 |
| Device Name: | Acumen Hypotension Prediction Index (HPI) Feature Software |
| Classification | Adjunctive Predictive Cardiovascular Indicator |
| Applicant | Edwards Lifesciences LLC one Edwards Way Irvine, CA 92614 |
| Contact | Lisa Gilman |
| Product Code | QAQ |
| CFR Regulation Number | 870.2210 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
| Review Advisory Board | Cardiovascular |
| Classification Advisory | Cardiovascular |
| Type | Direct |
| Date Received | 2016-09-26 |
| Decision Date | 2018-03-16 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |