Clearance Summary
VERICHIP HEALTH INFORMATION MICROTRANSPONDER AND POCKET READER received FDA 510(k) clearance under submission number DEN040007, sponsored by Digital Angel Corporation. The device was reviewed via the Post-NSE premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2004-10-12.
- Submission: DEN040007
- Applicant / Sponsor: Digital Angel Corporation
- Clearance pathway: Post-NSE
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6300
- Decision date: 2004-10-12
Classification & Regulation
This clearance is catalogued under FDA product code NRV and 21 CFR 880.6300, within the General Hospital review panel as a Class II device.