Clearance Summary
R AND D BATTERIES, INC. PART NUMBERS 5310, 5063 & 5211 received FDA 510(k) clearance under submission number K934660, sponsored by R & D Batteries, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1993-12-03.
- Submission: K934660
- Applicant / Sponsor: R & D Batteries, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2800
- Decision date: 1993-12-03
Classification & Regulation
This clearance is catalogued under FDA product code DSH and 21 CFR 870.2800, within the Cardiovascular review panel as a Class II device.