Clearance Summary
R AND D BATTERIES received FDA 510(k) clearance under submission number K935427, sponsored by R & D Batteries, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1994-10-21.
- Submission: K935427
- Applicant / Sponsor: R & D Batteries, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1540
- Decision date: 1994-10-21
Classification & Regulation
This clearance is catalogued under FDA product code JAF and 21 CFR 892.1540, within the Radiology review panel as a Class II device.