FDA 510(k) Application Details - K142624

Device Classification Name	Stimulator, Electrical, Evoked Response   More FDA Info for this Device
510(K) Number	K142624
Device Name	Stimulator, Electrical, Evoked Response
Applicant	Nihon Kohden Corporation 1-31-4 Nisahiochiai, Shinjuku-Ku Tokyo 161-8560 JP Other 510(k) Applications for this Company
Contact	Natalie Kennel 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	09/16/2014
Decision Date	04/24/2015
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