FDA 510(k) Application Details - K130238

Device Classification Name	Amplitude-Integrated Electroencephalograph   More FDA Info for this Device
510(K) Number	K130238
Device Name	Amplitude-Integrated Electroencephalograph
Applicant	NIHON KOHDEN CORP. 13721 VIA TRES VISTA SAN DIEGO, CA 92129 US Other 510(k) Applications for this Company
Contact	NATALIE KENNEL 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	01/31/2013
Decision Date	03/04/2015
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