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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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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 Number880.5735
Classification Product Code
QXC  
Date Received09/21/2022
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
Predetermined Change
Control Plan Authorized		 No
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