Clearance Summary
HEARTTRENDS received FDA 510(k) clearance under submission number K012825, sponsored by Lev-El, Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2002-03-19.
- Submission: K012825
- Applicant / Sponsor: Lev-El, Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1425
- Decision date: 2002-03-19
Classification & Regulation
This clearance is catalogued under FDA product code DQK and 21 CFR 870.1425, within the Cardiovascular review panel as a Class II device.