FDA 510(k) Application Details - K964280

Device Classification Name	Electroencephalograph   More FDA Info for this Device
510(K) Number	K964280
Device Name	Electroencephalograph
Applicant	MEDELEC LTD. MANOR WAY OLD WOKING, SURREY GU22 9JU DE Other 510(k) Applications for this Company
Contact	CAROL BLEAKLEY Other 510(k) Applications for this Contact
Regulation Number	882.1400   More FDA Info for this Regulation Number
Classification Product Code	GWQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/28/1996
Decision Date	01/27/1997
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