Clearance Summary
R&D PART 5518, 5306, 5315 AND 5457 received FDA 510(k) clearance under submission number K945867, 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 1994-12-29.
- Submission: K945867
- Applicant / Sponsor: R & D Batteries, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.1500
- Decision date: 1994-12-29
Classification & Regulation
This clearance is catalogued under FDA product code FCO and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class I device.