Skip to contentDe Novo DEN200042
- Device
- BrainTemp Neonate System (BTNeo System)
- Contact
- david anderson
- De Novo number
- DEN200042
- Product code
- QSL
- Regulation
- 882.1565
- Classification name
- brain temperature measurement system
- Decision
- granted (DENG)
- Decision date
- 2022-03-29
- Date received
- 2020-06-23
- Classification advisory
- Neurology
- Review advisory
- Neurology
- Type
- Direct
Current FDA Classification#
- Product code
- QSL
- Device name
- Brain Temperature Measurement System
- Medical specialty
- Neurology
- Device class
- 2
- Regulation
- 882.1565
- Implant
- N
- Life sustain/support
- N