Clearance Summary
BETA MULTI-PROCEDURE MOBILE UROLOGICAL TABLE, MODEL S5005 received FDA 510(k) clearance under submission number K954278, sponsored by Beta Medical Products, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 1995-10-02.
- Submission: K954278
- Applicant / Sponsor: Beta Medical Products, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.4890
- Decision date: 1995-10-02
Classification & Regulation
This clearance is catalogued under FDA product code MMZ and 21 CFR 876.4890, within the Gastroenterology, Urology review panel as a Class II device.