Definition: To Reduce Microbial Populations
Device Type ID | 2728 |
Device Name | Antimicrobial Keyboard |
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 Description | Ultraviolet (UV) Radiation Chamber Disinfection Device. |
Regulation Medical Specialty | General Hospital |
Review Panel | General 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 Type | 510(k) |
CFR Regulation Number | 880.6600 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | OSZ |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 2728 |
Device | Antimicrobial Keyboard |
Product Code | OSZ |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Ultraviolet (UV) Radiation Chamber Disinfection Device. |
CFR Regulation Number | 880.6600 [🔎] |