Clearance Summary
R & D BATTERIES, INC. PART NUMBER 5447 received FDA 510(k) clearance under submission number K935467, sponsored by R & D Batteries, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 1994-04-19.
- Submission: K935467
- Applicant / Sponsor: R & D Batteries, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.5380
- Decision date: 1994-04-19
Classification & Regulation
This clearance is catalogued under FDA product code BXB and 21 CFR 890.5380, within the Physical Medicine review panel as a Class I device.