Skip to contentDe Novo DEN200033
- Device
- NightWare Kit, Apple iPhone, Apple Watch, Apple iPhone Charging Cable, Apple Watch Charging Cable
- Contact
- grady hannah
- De Novo number
- DEN200033
- Product code
- QMZ
- Regulation
- 882.5705
- Classification name
- digital therapy device to reduce sleep disturbance for psychiatric conditions
- Decision
- granted (DENG)
- Decision date
- 2020-11-06
- Date received
- 2020-05-27
- Classification advisory
- Neurology
- Review advisory
- Neurology
- Type
- Direct
Current FDA Classification#
- Product code
- QMZ
- Device name
- Digital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions
- Medical specialty
- Neurology
- Device class
- 2
- Regulation
- 882.5705
- Implant
- N
- Life sustain/support
- N