Clearance Summary
Us2.ca received FDA 510(k) clearance under submission number K250151, sponsored by Eko.Ai Pte Ltd. D/B/A Us2.Ai. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2025-06-20.
- Submission: K250151
- Applicant / Sponsor: Eko.Ai Pte Ltd. D/B/A Us2.Ai
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2200
- Decision date: 2025-06-20
Classification & Regulation
This clearance is catalogued under FDA product code SDJ and 21 CFR 870.2200, within the Cardiovascular review panel as a Class II device.