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U.S. Department of Health and Human Services

Product Classification

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Device antimicrobial keyboard
Regulation Description Ultraviolet (UV) radiation chamber disinfection device.
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 Surgical and Infection Control Devices (OHT4)
Infection Control and Plastic Surgery Devices (DHT4B)
Submission Type 510(k)
Regulation Number 880.6600
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons
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