Clearance Summary
KENEX MOBILE CASSETT HOLDER (AS EXHIBIT #7) received FDA 510(k) clearance under submission number K951006, sponsored by Kenex , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1995-04-03.
- Submission: K951006
- Applicant / Sponsor: Kenex , Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1850
- Decision date: 1995-04-03
Classification & Regulation
This clearance is catalogued under FDA product code IXA and 21 CFR 892.1850, within the Radiology review panel as a Class II device.