FDA 510(k) Application Details - K970703

Device Classification Name	Electroencephalograph   More FDA Info for this Device
510(K) Number	K970703
Device Name	Electroencephalograph
Applicant	BIOSOUND ESAOTE, INC. 8000 CASTLEWAY DR. INDIANAPOLIS, IN 46250 US Other 510(k) Applications for this Company
Contact	GERALD A RICHARDSON 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	02/26/1997
Decision Date	05/19/1997
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