Skip to contentDe Novo DEN230067
- Device
- Chronos®
- Contact
- vincent gardes
- De Novo number
- DEN230067
- Product code
- SCS
- Regulation
- 880.6511
- Classification name
- ultraviolet radiation disinfection chamber device
- Decision
- granted (DENG)
- Decision date
- 2024-08-28
- Date received
- 2023-09-28
- Classification advisory
- General Hospital
- Review advisory
- General Hospital
- Type
- Direct
Current FDA Classification#
- Product code
- SCS
- Device name
- Ultraviolet Radiation Disinfection Chamber Device
- Medical specialty
- General Hospital
- Device class
- 2
- Regulation
- 880.6511
- Implant
- N
- Life sustain/support
- N