FDA 510(k) Application Details - K163644

Device Classification Name	Amplitude-Integrated Electroencephalograph   More FDA Info for this Device
510(K) Number	K163644
Device Name	Amplitude-Integrated Electroencephalograph
Applicant	Nihon Kohden Corporation 1-31-4 Nishiochiai, Shinjuku-Ku Tokyo 161-8560 JP Other 510(k) Applications for this Company
Contact	Tom Bento Other 510(k) Applications for this Contact
Regulation Number	882.1400   More FDA Info for this Regulation Number
Classification Product Code	OMA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/23/2016
Decision Date	05/19/2017
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