AHI System is an AI-enabled medical device from Fifth Eye Inc., listed by FDA (510(k), K212219) with a decision date of 2021-12-03. Review panel: Cardiovascular.
| FDA submission number | K212219 |
|---|---|
| Pathway | 510(k) |
| Company | Fifth Eye Inc. |
| Review panel (specialty) | Cardiovascular |
| FDA decision date | 2021-12-03 |
| Decision | Substantially Equivalent |
| Product code | QNV |
| Classification | Adjunctive Hemodynamic Indicator With Decision Point |
| Device class | 2 |
| Regulation number | 870.2220 |
| Review time (calendar days) | 140 |
| Applicant country | US |
Official FDA database record · FDA AI-enabled device list
More devices from Fifth Eye Inc. · All Cardiovascular AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.