Clearance Summary
NONINVASIVE BLOOD PRESSURE MEASUREMENT SYSTEM received FDA 510(k) clearance under submission number K002791, sponsored by Unix Electronic Co. , 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 2001-01-29.
- Submission: K002791
- Applicant / Sponsor: Unix Electronic Co. , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1130
- Decision date: 2001-01-29
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.