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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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De Novo Number DEN200026
Device Name EndeavorRx
Requester
Akili Interactive Labs Inc.
125 broad street, 4th floor
boston,  MA  02110
Contact scott kellogg
Classification Product Code
QFT
Date Received04/16/2020
Decision Date 06/15/2020
Decision granted (DENG)
Review Advisory Committee Neurology
Reclassification Order Reclassification Order
Type Direct
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