APPRAISE-HRI is an AI-enabled medical device from The Surgeon General, Department of the Army (TSG-DA), listed by FDA (510(k), K233249) with a decision date of 2024-04-05. Review panel: Cardiovascular.
| FDA submission number | K233249 |
|---|---|
| Pathway | 510(k) |
| Company | The Surgeon General, Department of the Army (TSG-DA) |
| Review panel (specialty) | Cardiovascular |
| FDA decision date | 2024-04-05 |
| Decision | Substantially Equivalent |
| Product code | SAR |
| Classification | Adjunctive Hemodynamic Indicator With Decision Point For Military Use |
| Device class | 2 |
| Regulation number | 870.2220 |
| Review time (calendar days) | 190 |
| Applicant country | US |
Official FDA database record · FDA AI-enabled device list
All Cardiovascular AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.