Clearance Summary
ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010) received FDA 510(k) clearance under submission number K250652, sponsored by Anumana, 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 2025-07-28.
- Submission: K250652
- Applicant / Sponsor: Anumana, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2380
- Decision date: 2025-07-28
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.