510(k) DEN220058
- Device
- BT-001
- Applicant
- Better Therapeutics
- 510(k) number
- DEN220058
- Product code
- QXC
- Decision
- Unknown (DENG)
- Decision date
- 2023-07-07
- Date received
- 2022-09-21
- Regulation
- 880.5735
- Classification name
- Diabetes Digital Therapeutic Device
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Heather Hill
- Address
- 548 Market St. #49404 San Francisco CA US 94104 94104
Source Documents#
510(k) summary PDF not indicated by FDA