Ultraviolet Radiation Disinfection Chamber Device
An ultraviolet radiation disinfection chamber device is a hospital device intended to disinfect patient-contacting medical devices using UV radiation within an enclosed chamber, after the devices have been cleaned, as an additional layer of infection control prior to patient use. It is classified as FDA Class II (510(k) required) under regulation 880.6511 in the General Hospital specialty, with product code SCS. The device is not an implant and does not support life-sustaining functions.
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Basic Information
- Product Code
- SCS
- Device Class
- FDA class 2
- Regulation Number
- 880.6511
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 1
Device Characteristics
Definition
An ultraviolet radiation disinfection chamber device is intended to disinfect patient contacting medical devices using UV radiation after the device has been cleaned. Disinfection of the medical device is achieved within an enclosed chamber through the exposure to UV radiation.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.