Clearance Summary
KODEA, MODELS XJ-2001AC; XJ-2002AS; XJ-2003A received FDA 510(k) clearance under submission number K062893, sponsored by Shanghai Kodea Economic and Trade Development , 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 2007-02-05.
- Submission: K062893
- Applicant / Sponsor: Shanghai Kodea Economic and Trade Development , Ltd.
- Clearance pathway: Abbreviated
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1130
- Decision date: 2007-02-05
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.