FDA 510(k) Application Details - K120485

Device Classification Name	Amplitude-Integrated Electroencephalograph   More FDA Info for this Device
510(K) Number	K120485
Device Name	Amplitude-Integrated Electroencephalograph
Applicant	NIHON KOHDEN AMERICA, INC. 90 ICON ST. FOOTHILL RANCH, CA 92610-1601 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	OMA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/17/2012
Decision Date	03/16/2012
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