Antimicrobial Keyboard

Device Code: 2728

Product Code(s): OSZ

Definition: To Reduce Microbial Populations

Device Classification Information

Device Type ID2728
Device NameAntimicrobial Keyboard
Physical StateDevice 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 MethodSelf Disinfecting Computer Keyboard And Touchpad That Utilized Germicidal Ultraviolet Light In An Enclosure
Target AreaHands
Regulation DescriptionUltraviolet (UV) Radiation Chamber Disinfection Device.
Regulation Medical SpecialtyGeneral Hospital
Review PanelGeneral Hospital
Premarket Review Office Of Device Evaluation (ODE)
Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID)
Infection Control Devices Branch (INCB)
Submission Type510(k)
CFR Regulation Number880.6600 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeOSZ
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID2728
DeviceAntimicrobial Keyboard
Product CodeOSZ
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionUltraviolet (UV) Radiation Chamber Disinfection Device.
CFR Regulation Number880.6600 [🔎]
TPLC Last Update: 2019-04-02 20:17:59

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