Device Classification Name |
Digital Therapeutic Software For Attention Deficit Hyperactivity Disorder
|
510(k) Number |
K231337 |
FOIA Releasable 510(k) |
K231337
|
Device Name |
EndeavorRx |
Applicant |
Akili Interactive Labs, Inc. |
125 Broad Street, 5th Floor |
Boston,
MA
02110
|
|
Applicant Contact |
Bhupinder Singh |
Correspondent |
Hogan Lovells U.S. LLP |
22 Boston Wharf Road |
7th Floor |
Boston,
MA
02210
|
|
Correspondent Contact |
Bhupinder Singh |
Regulation Number | 882.5803
|
Classification Product Code |
|
Date Received | 05/08/2023 |
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
|
|
|