De Novo DEN230007
- Device
- LightStrike+ (MXSUV1-SL and MXSUV1-FT)
- Contact
- juan l. gonzalez
- De Novo number
- DEN230007
- Product code
- QXJ
- Regulation
- 880.6510
- Classification name
- whole room microbial reduction device
- Decision
- granted (DENG)
- Decision date
- 2023-09-01
- Date received
- 2023-02-01
- Classification advisory
- General Hospital
- Review advisory
- General Hospital
- Type
- Direct
Current FDA Classification#
- Product code
- QXJ
- Device name
- Whole Room Microbial Reduction Device
- Medical specialty
- General Hospital
- Device class
- 2
- Regulation
- 880.6510
- Implant
- N
- Life sustain/support
- N