De Novo DEN180024
- Device
- Leica FL400
- Contact
- grainne griffin
- De Novo number
- DEN180024
- Product code
- QFX
- Regulation
- 882.4950
- Classification name
- diagnostic neurosurgical microscope filter
- Decision
- granted (DENG)
- Decision date
- 2019-03-28
- Date received
- 2018-04-27
- Classification advisory
- Neurology
- Review advisory
- Neurology
- Type
- Direct
Current FDA Classification#
- Product code
- QFX
- Device name
- Diagnostic Neurosurgical Microscope Filter
- Medical specialty
- Neurology
- Device class
- 2
- Regulation
- 882.4950
- Implant
- N
- Life sustain/support
- N