FDA 510(k) Application Details - K001101

Device Classification Name	Stimulator, Electrical, Evoked Response   More FDA Info for this Device
510(K) Number	K001101
Device Name	Stimulator, Electrical, Evoked Response
Applicant	EXCEL TECH. LTD. 2568 BRISTOL CIRCLE OAKVILLE, ONTARIO L6H 5S1 CA Other 510(k) Applications for this Company
Contact	DEBBIE DAVY 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	04/05/2000
Decision Date	06/30/2000
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