Clearance Summary
QUANTA BLOOD PRESSURE METER, MODEL: CARDIAC ELITE 1000 OR QH200 received FDA 510(k) clearance under submission number K083078, sponsored by Quanta Computer, 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 2008-11-26.
- Submission: K083078
- Applicant / Sponsor: Quanta Computer, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1130
- Decision date: 2008-11-26
Classification & Regulation
This clearance is catalogued under FDA product code DXN and 21 CFR 870.1130, within the Cardiovascular review panel as a Class II device.