De Novo DEN200026
- Device
- EndeavorRx
- Contact
- scott kellogg
- De Novo number
- DEN200026
- Product code
- QFT
- Regulation
- 882.5803
- Classification name
- digital therapeutic software for attention deficit hyperactivity disorder
- Decision
- granted (DENG)
- Decision date
- 2020-06-15
- Date received
- 2020-04-16
- Classification advisory
- Obstetrics/Gynecology
- Review advisory
- Neurology
- Type
- Direct
Current FDA Classification#
- Product code
- QFT
- Device name
- Digital Therapeutic Software For Attention Deficit Hyperactivity Disorder
- Medical specialty
- Obstetrics/Gynecology
- Device class
- 2
- Regulation
- 882.5803
- Implant
- N
- Life sustain/support
- N