Device Classification Name |
diabetes digital therapeutic device
|
De Novo Number |
DEN220058 |
Device Name |
BT-001 |
Requester |
better therapeutics |
548 market st. #49404 |
san francisco,
CA
94104
|
|
Contact |
heather hill |
|
Regulation Number | 880.5735
|
Classification Product Code |
|
Date Received | 09/21/2022 |
Decision Date | 07/07/2023 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
General Hospital
|
Review Advisory Committee |
Clinical Chemistry
|
Classification Order |
Classification Order
|
FDA Review |
Decision Summary
|
Type |
Direct
|
|
|