510(k) DEN230067
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- August 28, 2024
- Date Received
- September 28, 2023
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ultraviolet Radiation Disinfection Chamber Device
- Device Class
- Class II
- Regulation Number
- 880.6511
- Review Panel
- HO
- Submission Type
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.