FDA 510(k) Application Details - K082614

Device Classification Name	Stimulator, Electrical, Evoked Response   More FDA Info for this Device
510(K) Number	K082614
Device Name	Stimulator, Electrical, Evoked Response
Applicant	LABORIE MEDICAL TECHNOLOGIES, INC. 400 AVENUE D SUITE 10 WILLISTON, VT 05495 US Other 510(k) Applications for this Company
Contact	BARBARA MORNET 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	09/09/2008
Decision Date	03/06/2009
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