Clearance Summary
ADVANTAGE CUFF, NON-INVASIVE BLOOD PRESSURE HOSE AND ADAPTER received FDA 510(k) clearance under submission number K063863, sponsored by Advantage Medical Cables, 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 2007-03-20.
- Submission: K063863
- Applicant / Sponsor: Advantage Medical Cables, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1120
- Decision date: 2007-03-20
Classification & Regulation
This clearance is catalogued under FDA product code DXQ and 21 CFR 870.1120, within the Cardiovascular review panel as a Class II device.