Clearance Summary
R &D BATTERIES, INC. PART # 5015, 5192, 5482 received FDA 510(k) clearance under submission number K933513, 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 1993-11-24.
- Submission: K933513
- Applicant / Sponsor: R & D Batteries, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1100
- Decision date: 1993-11-24
Classification & Regulation
This clearance is catalogued under FDA product code IYX and 21 CFR 892.1100, within the Radiology review panel as a Class I device.