Clearance Summary
KTJ-20C BLOOD PRESSURE CUFF, MODEL KTJ-20C received FDA 510(k) clearance under submission number K010686, sponsored by Golden Horse Medical Equipment (Wuxi) Co. , 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 2001-03-21.
- Submission: K010686
- Applicant / Sponsor: Golden Horse Medical Equipment (Wuxi) Co. , Ltd.
- Clearance pathway: Abbreviated
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1120
- Decision date: 2001-03-21
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.