Clearance Summary
VIOGUARD SELF-SANITIZING KEYBOARD, MODEL UVKB50 received FDA 510(k) clearance under submission number DEN100013, sponsored by Vioguard. 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 2011-12-20.
- Submission: DEN100013
- Applicant / Sponsor: Vioguard
- Clearance pathway: Post-NSE
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6600
- Decision date: 2011-12-20
Classification & Regulation
This clearance is catalogued under FDA product code OSZ and 21 CFR 880.6600, within the General Hospital review panel as a Class II device.