Clearance Summary
BATTERY PACKS (VARIOUS MODELS) received FDA 510(k) clearance under submission number K931200, sponsored by Access / God Loves You. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1993-07-13.
- Submission: K931200
- Applicant / Sponsor: Access / God Loves You
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1720
- Decision date: 1993-07-13
Classification & Regulation
This clearance is catalogued under FDA product code IZL and 21 CFR 892.1720, within the Radiology review panel as a Class II device.