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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name digital therapeutic software for attention deficit hyperactivity disorder
510(k) Number K231337
Device Name EndeavorRx
Akili Interactive Labs, Inc.
125 Broad Street, 5th Floor
Boston,  MA  02110
Applicant Contact Bhupinder Singh
Hogan Lovells U.S. LLP
22 Boston Wharf Road
7th Floor
Boston,  MA  02210
Correspondent Contact Bhupinder Singh
Regulation Number882.5803
Classification Product Code
Date Received05/08/2023
Decision Date 12/13/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Neurology
Summary Summary
Type Traditional
Clinical Trials NCT04897074
Reviewed by Third Party No
Combination Product No