De Novo DEN170072
- Device
- Enlight 1810
- Contact
- rafael holzhacker
- De Novo number
- DEN170072
- Product code
- QEB
- Regulation
- 868.1505
- Classification name
- ventilatory electrical impedance tomograph
- Decision
- granted (DENG)
- Decision date
- 2018-12-20
- Date received
- 2017-09-29
- Classification advisory
- Anesthesiology
- Review advisory
- Anesthesiology
- Type
- Direct
Current FDA Classification#
- Product code
- QEB
- Device name
- Ventilatory Electrical Impedance Tomograph
- Medical specialty
- Anesthesiology
- Device class
- 2
- Regulation
- 868.1505
- Implant
- N
- Life sustain/support
- N