SCS · Class II — Moderate Risk (510(k) clearance required) · General Hospital · 21 CFR 880.6511
Classification
FDA Product Code
SCS
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 880.6511
Review panel
HO
Medical specialty
General Hospital
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.