FDA 510(k) Application Details - K061113

Device Classification Name	Stimulator, Electrical, Evoked Response   More FDA Info for this Device
510(K) Number	K061113
Device Name	Stimulator, Electrical, Evoked Response
Applicant	AXON SYSTEMS, INC. 400-2200 OSER AVE. HAUPPAUGE, NY 11788 US Other 510(k) Applications for this Company
Contact	HOWARD BAILIN 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	04/21/2006
Decision Date	05/23/2006
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