FDA 510(k) Application Details - K971214

Device Classification Name	Stimulator, Photic, Evoked Response   More FDA Info for this Device
510(K) Number	K971214
Device Name	Stimulator, Photic, Evoked Response
Applicant	CADWELL LABORATORIES, INC. 909 NORTH KELLOGG ST. KENNEWICK, WA 99336 US Other 510(k) Applications for this Company
Contact	CARLTON CADWELL Other 510(k) Applications for this Contact
Regulation Number	882.1890   More FDA Info for this Regulation Number
Classification Product Code	GWE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/02/1997
Decision Date	06/11/1998
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