FDA 510(k) Application Details - K120888

Device Classification Name	Electroencephalograph   More FDA Info for this Device
510(K) Number	K120888
Device Name	Electroencephalograph
Applicant	NIHON KOHDEN CORP. 90 ICON STREET FOOTHILL RANCH, CA 92610 US Other 510(k) Applications for this Company
Contact	STEVE GEERDES 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	03/23/2012
Decision Date	11/09/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review