De Novo DEN220058
- Device
- BT-001
- Contact
- heather hill
- De Novo number
- DEN220058
- Product code
- QXC
- Regulation
- 880.5735
- Classification name
- diabetes digital therapeutic device
- Decision
- granted (DENG)
- Decision date
- 2023-07-07
- Date received
- 2022-09-21
- Classification advisory
- General Hospital
- Review advisory
- Clinical Chemistry
- Type
- Direct
Current FDA Classification#
- Product code
- QXC
- Device name
- Diabetes Digital Therapeutic Device
- Medical specialty
- General Hospital
- Device class
- 2
- Regulation
- 880.5735
- Implant
- N
- Life sustain/support
- N