Clearance Summary
DARPAC 2000 SUPERFICIAL X-RAY THERAPY SYSTEM received FDA 510(k) clearance under submission number K962613, sponsored by Gulmay Medical , 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 1996-09-27.
- Submission: K962613
- Applicant / Sponsor: Gulmay Medical , Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5900
- Decision date: 1996-09-27
Classification & Regulation
This clearance is catalogued under FDA product code JAD and 21 CFR 892.5900, within the Radiology review panel as a Class II device.