Clearance Summary
2001 SPECIAL PROCEDURE LAMP (LOW VOLTAGE) (AS EXHIBITS #2 & 4) received FDA 510(k) clearance under submission number K951004, 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 1995-04-10.
- Submission: K951004
- Applicant / Sponsor: Kenex , Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.6500
- Decision date: 1995-04-10
Classification & Regulation
This clearance is catalogued under FDA product code KPY and 21 CFR 892.6500, within the Radiology review panel as a Class I device.