510(k) DEN100013
DEN100013 is an FDA 510(k) premarket notification submitted by Vioguard for the device "VIOGUARD SELF-SANITIZING KEYBOARD, MODEL UVKB50". The FDA issued a decision of De Novo Granted on December 20, 2011. The device falls under product code OSZ (Antimicrobial Keyboard), a Class II device regulated under 21 CFR 880.6600.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- December 20, 2011
- Date Received
- November 5, 2010
- Clearance Type
- Post-NSE
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antimicrobial Keyboard
- Device Class
- Class II
- Regulation Number
- 880.6600
- Review Panel
- HO
- Submission Type
To reduce microbial populations