Eko Low Ejection Fraction Tool (ELEFT) is an AI-enabled medical device from Eko Health, Inc., listed by FDA (510(k), K233409) with a decision date of 2024-03-28. Review panel: Cardiovascular.
| FDA submission number | K233409 |
|---|---|
| Pathway | 510(k) |
| Company | Eko Health, Inc. |
| Review panel (specialty) | Cardiovascular |
| FDA decision date | 2024-03-28 |
| Decision | Substantially Equivalent |
| Product code | QYE |
| Classification | Reduced Ejection Fraction Machine Learning-Based Notification Software |
| Device class | 2 |
| Regulation number | 870.2380 |
| Review time (calendar days) | 174 |
| 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.