Clearance Summary
BATTERY PACKS received FDA 510(k) clearance under submission number K923305, sponsored by Access / God Loves You. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 1992-12-17.
- Submission: K923305
- Applicant / Sponsor: Access / God Loves You
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.1400
- Decision date: 1992-12-17
Classification & Regulation
This clearance is catalogued under FDA product code CCK and 21 CFR 868.1400, within the Anesthesiology review panel as a Class II device.