De Novo DEN140032
- Device
- Cereve Sleep System
- Contact
- eric nofzinger
- De Novo number
- DEN140032
- Product code
- PLU
- Regulation
- 882.5700
- Classification name
- thermal system for insomnia
- Decision
- granted (DENG)
- Decision date
- 2016-05-13
- Date received
- 2014-10-20
- Classification advisory
- Neurology
- Review advisory
- Neurology
- Type
- Direct
Current FDA Classification#
- Product code
- PLU
- Device name
- Thermal System For Insomnia
- Medical specialty
- Neurology
- Device class
- 2
- Regulation
- 882.5700
- Implant
- N
- Life sustain/support
- N