FDA 510(k) Application Details - K993177

Device Classification Name	Stimulator, Auditory, Evoked Response   More FDA Info for this Device
510(K) Number	K993177
Device Name	Stimulator, Auditory, Evoked Response
Applicant	SLE LIMITED PO BOX 12038 LA JOLLA, CA 92037 US Other 510(k) Applications for this Company
Contact	FRANK FERGUSON Other 510(k) Applications for this Contact
Regulation Number	882.1900   More FDA Info for this Regulation Number
Classification Product Code	GWJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/23/1999
Decision Date	11/16/1999
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