FDA 510(k) Application Details - K010997

Device Classification Name	Electroencephalograph   More FDA Info for this Device
510(K) Number	K010997
Device Name	Electroencephalograph
Applicant	INDIVIDUAL MONITORING SYSTEMS, INC. 1055 TAYLOR AVE., SUITE 300 BALTIMORE, MD 21286-8334 US Other 510(k) Applications for this Company
Contact	DAVID T KRAUSMAN 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	04/03/2001
Decision Date	10/15/2001
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