Acumen Assisted Fluid Management (AFM) Software Feature is an AI-enabled medical device from Edwards Lifesciences, LLC, listed by FDA (510(k), K233984) with a decision date of 2024-08-02. Review panel: Cardiovascular.
| FDA submission number | K233984 |
|---|---|
| Pathway | 510(k) |
| Company | Edwards Lifesciences, LLC |
| Review panel (specialty) | Cardiovascular |
| FDA decision date | 2024-08-02 |
| Decision | Substantially Equivalent |
| Product code | QMS |
| Classification | Adjunctive Open Loop Fluid Therapy Recommender |
| Device class | 2 |
| Regulation number | 870.5600 |
| Review time (calendar days) | 228 |
| Applicant country | US |
Official FDA database record · FDA AI-enabled device list
More devices from Edwards Lifesciences, LLC · All Cardiovascular AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.