FDA 510(k) Application Details - K120397

Device Classification Name	Stimulator, Electrical, Evoked Response   More FDA Info for this Device
510(K) Number	K120397
Device Name	Stimulator, Electrical, Evoked Response
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	882.1870   More FDA Info for this Regulation Number
Classification Product Code	GWF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/08/2012
Decision Date	09/19/2012
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