Product code SCS

Device name

Ultraviolet Radiation Disinfection Chamber Device

Medical specialty

General Hospital

Device class

2

Regulation number

880.6511

Review panel

HO

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset