FDA 510(k) Application Details - K143233

Device Classification Name	Electroencephalograph   More FDA Info for this Device
510(K) Number	K143233
Device Name	Electroencephalograph
Applicant	MITSAR CO., LTD Novorossiyskaya str. 21-2 St. Petersburg 194021 RU Other 510(k) Applications for this Company
Contact	Semchenkov Ales Other 510(k) Applications for this Contact
Regulation Number	882.1400   More FDA Info for this Regulation Number
Classification Product Code	GWQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/10/2014
Decision Date	08/13/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review