Clearance Summary
MULTIPLE, MODEL KTJ-50 received FDA 510(k) clearance under submission number K043444, sponsored by Golden Horse Medical Equipment (Wuxi) 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 2005-02-22.
- Submission: K043444
- Applicant / Sponsor: Golden Horse Medical Equipment (Wuxi) Co. , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1120
- Decision date: 2005-02-22
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.