FDA 510(k) Application Details - K143468

Device Classification Name	Recorder, Attention Task Performance   More FDA Info for this Device
510(K) Number	K143468
Device Name	Recorder, Attention Task Performance
Applicant	QBTECH AB Kungsgatan 29 Stockholm 11156 SE Other 510(k) Applications for this Company
Contact	Hans Bostrom Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LQD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/04/2014
Decision Date	03/22/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review