FDA 510(k) Application Details - DEN200026

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN200026
Device Name	EndeavorRx
Applicant	Akili Interactive Labs Inc. 125 Broad Street, 4th Floor Boston, MA 02110 US Other 510(k) Applications for this Company
Contact	Scott Kellogg 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	04/16/2020
Decision Date	06/15/2020
Decision	DENG -
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review