Clearance Summary
NILIMEDIX ADI received FDA 510(k) clearance under submission number K070844, sponsored by Nilimedix , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2008-06-06.
- Submission: K070844
- Applicant / Sponsor: Nilimedix , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5725
- Decision date: 2008-06-06
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.