FDA 510(k) Application Details - K161328

Device Classification Name	More FDA Info for this Device
510(K) Number	K161328
Device Name	Cantab Mobile
Applicant	CAMBRIDGE COGNITION LTD., US AGENT: CLEMENTI ASSOCIATES LTD. TUNBRIDGE COURT, TUNBRIDGE LANE Bottisham CB25 9TU GB Other 510(k) Applications for this Company
Contact	Nancy D. Clementi Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PKQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/12/2016
Decision Date	01/13/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review