FDA 510(k) Application Details - DEN150037

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN150037
Device Name	ImPACT Computerized Neurocognitive Concussion Management Aid
Applicant	IMPACT APPLICATIONS, INC. 2000 TECHNOLOGY DRIVE, SUITE 150 PITTSBURGH, PA 15219 US Other 510(k) Applications for this Company
Contact	MICHAEL ZAGORSKI Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	POM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/11/2015
Decision Date	08/22/2016
Decision	DENG -
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review