De Novo DEN200029
- Device
- Parallel
- Contact
- jean-noel courvoisier
- De Novo number
- DEN200029
- Product code
- QMY
- Regulation
- 876.5960
- Classification name
- computerized behavioral therapy device for treating symptoms
- Decision
- granted (DENG)
- Decision date
- 2020-11-25
- Date received
- 2020-04-30
- Classification advisory
- Gastroenterology/Urology
- Review advisory
- Gastroenterology/Urology
- Type
- Direct
Current FDA Classification#
- Product code
- QMY
- Device name
- Computerized Behavioral Therapy Device For Treating Symptoms
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation
- 876.5960
- Implant
- N
- Life sustain/support
- N