SCS

2 FDA 510(k) clearances · Product code

FDA profile

Official device name

Ultraviolet Radiation Disinfection Chamber Device

Device class

Class II (moderate risk)

Regulation

21 CFR 880.6511

Medical specialty

General Hospital

FDA 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.

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