Clearance Summary
INTCO TAB ELECTRODE received FDA 510(k) clearance under submission number K093327, sponsored by Shanghai Intco Electrode Manufacturing 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 2010-05-10.
- Submission: K093327
- Applicant / Sponsor: Shanghai Intco Electrode Manufacturing Co., Ltd.
- Clearance pathway: Abbreviated
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2360
- Decision date: 2010-05-10
Classification & Regulation
This clearance is catalogued under FDA product code DRX and 21 CFR 870.2360, within the Cardiovascular review panel as a Class II device.