Clearance Summary
EUREKA EXTENSION CYLINDERS received FDA 510(k) clearance under submission number K904489, sponsored by Eureka X-Ray Tube Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1990-10-15.
- Submission: K904489
- Applicant / Sponsor: Eureka X-Ray Tube Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1610
- Decision date: 1990-10-15
Classification & Regulation
This clearance is catalogued under FDA product code KPW and 21 CFR 892.1610, within the Radiology review panel as a Class II device.