FDA 510(k) Application Details - K231337

Device Classification Name	More FDA Info for this Device
510(K) Number	K231337
Device Name	EndeavorRx
Applicant	Akili Interactive Labs, Inc. 125 Broad Street, 5th Floor Boston, MA 02110 US Other 510(k) Applications for this Company
Contact	Bhupinder Singh Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QFT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/08/2023
Decision Date	12/13/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review