Clearance Summary
R & D BATTERIES,INC. PART NUMBERS 5164, 5272, 5260 received FDA 510(k) clearance under submission number K933687, sponsored by R & D Batteries, 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 1994-02-09.
- Submission: K933687
- Applicant / Sponsor: R & D Batteries, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5630
- Decision date: 1994-02-09
Classification & Regulation
This clearance is catalogued under FDA product code FKX and 21 CFR 876.5630, within the Gastroenterology, Urology review panel as a Class II device.