FDA 510(k) Application Details - K965065

Device Classification Name	Stimulator, Electrical, Evoked Response   More FDA Info for this Device
510(K) Number	K965065
Device Name	Stimulator, Electrical, Evoked Response
Applicant	MEDELEC LTD. MANOR WAY OLD WOKING SURREY, ENGLAND GU22 9JU GB Other 510(k) Applications for this Company
Contact	JEFF HALL 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	12/18/1996
Decision Date	06/20/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review