Eko Foundation Analysis Software with Transformers (EFAST) is an AI-enabled medical device from Eko Health, Inc., listed by FDA (510(k), K251494) with a decision date of 2025-08-12. Review panel: Cardiovascular.
| FDA submission number | K251494 |
|---|---|
| Pathway | 510(k) |
| Company | Eko Health, Inc. |
| Review panel (specialty) | Cardiovascular |
| FDA decision date | 2025-08-12 |
| Decision | Substantially Equivalent |
| Product code | DQD |
| Classification | Stethoscope, Electronic |
| Device class | 2 |
| Regulation number | 870.1875 |
| Review time (calendar days) | 89 |
| 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.