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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 digital therapeutic software for attention deficit hyperactivity disorder
De Novo Number DEN200026
Device Name EndeavorRx
Requester
Akili Interactive Labs Inc.
125 broad street, 4th floor
boston,  MA  02110
Contact scott kellogg
Regulation Number882.5803
Classification Product Code
QFT  
Date Received04/16/2020
Decision Date 06/15/2020
Decision granted (DENG)
Classification Advisory Committee Obstetrics/Gynecology
Review Advisory Committee Neurology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct
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