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510(k) DEN220058

BT-001 by Better Therapeutics — Product Code QXC

Clearance Details

Decision: DENG (De Novo Granted)
Decision Date: July 7, 2023
Date Received: September 21, 2022
Clearance Type: Direct
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Diabetes Digital Therapeutic Device
Device Class: Class II
Regulation Number: 880.5735
Review Panel: CH
Submission Type

A diabetes digital behavioral therapeutic device is a prescription use software device that provides digital behavioral therapy to aid in the management of diabetes. This device is intended to provide limited secondary benefit to patients with diabetes mellitus by assisting them in managing their condition. This device is not intended to replace any primary treatment, such as diet/lifestyle changes or medication.