Clearance Summary
VENOMETER received FDA 510(k) clearance under submission number K983900, sponsored by Advanced Medical Technology , Ltd.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1999-01-29.
- Submission: K983900
- Applicant / Sponsor: Advanced Medical Technology , Ltd.
- Clearance pathway: Abbreviated
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2780
- Decision date: 1999-01-29
Classification & Regulation
This clearance is catalogued under FDA product code JOM and 21 CFR 870.2780, within the Cardiovascular review panel as a Class II device.