Clearance Summary
MEDICAL BATTERY PACKS received FDA 510(k) clearance under submission number K922910, sponsored by Access / God Loves You. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1992-09-30.
- Submission: K922910
- Applicant / Sponsor: Access / God Loves You
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.1570
- Decision date: 1992-09-30
Classification & Regulation
This clearance is catalogued under FDA product code HLJ and 21 CFR 886.1570, within the Ophthalmic review panel as a Class II device.