Clearance Summary
DANA DIABECARE IIS received FDA 510(k) clearance under submission number K063126, sponsored by Sooil Development Co., Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2007-02-02.
- Submission: K063126
- Applicant / Sponsor: Sooil Development Co., Ltd.
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5725
- Decision date: 2007-02-02
Classification & Regulation
This clearance is catalogued under FDA product code LZG and 21 CFR 880.5725, within the General Hospital review panel as a Class II device.