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U.S. Department of Health and Human Services

Product Classification

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Device antimicrobial keyboard
Definition To reduce microbial populations.
Physical State device resides on a motorized drawer that is contained in an enclosure, the drawer slides outside of the enclosure for use then retracts into the light-tight enclusure for UV disinfection after use
Technical Method self disinfecting computer keyboard and touchpad that utilized germicidal ultraviolet light in an enclosure
Target Area hands
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodeOSZ
Premarket Review Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
Infection Control Devices Branch (INCB)
Submission Type 510(k)
Regulation Number 880.6600
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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