FDA 510(k) Application Details - K112881

Device Classification Name	Stimulator, Electrical, Evoked Response   More FDA Info for this Device
510(K) Number	K112881
Device Name	Stimulator, Electrical, Evoked Response
Applicant	NEXSTIM OY ELIMAENKATU 9 B HELSINKI FI-00510 FI Other 510(k) Applications for this Company
Contact	RAINER HARJUNPAA 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	09/30/2011
Decision Date	05/22/2012
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