Acumen Hypotension Prediction Index (HPI) Feature Software is an AI-enabled medical device from Edwards Lifesciences LLC, listed by FDA (De Novo, DEN160044) with a decision date of 2018-03-16. Review panel: Cardiovascular.
| FDA submission number | DEN160044 |
|---|---|
| Pathway | De Novo |
| Company | Edwards Lifesciences LLC |
| Review panel (specialty) | Cardiovascular |
| FDA decision date | 2018-03-16 |
| Decision | Unknown |
| Product code | QAQ |
| Classification | Adjunctive Predictive Cardiovascular Indicator |
| Device class | 2 |
| Regulation number | 870.2210 |
| Review time (calendar days) | 536 |
| Applicant country | US |
Official FDA database record · FDA AI-enabled device list
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Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.