Clearance Summary
Eko Low Ejection Fraction Tool (ELEFT) received FDA 510(k) clearance under submission number K233409, sponsored by Eko Health, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2024-03-28.
- Submission: K233409
- Applicant / Sponsor: Eko Health, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2380
- Decision date: 2024-03-28
Classification & Regulation
This clearance is catalogued under FDA product code QYE and 21 CFR 870.2380, within the Cardiovascular review panel as a Class II device.