FDA 510(k) Application Details - K003681

Device Classification Name	Standard Polysomnograph With Electroencephalograph   More FDA Info for this Device
510(K) Number	K003681
Device Name	Standard Polysomnograph With Electroencephalograph
Applicant	BIO-LOGIC SYSTEMS CORP. ONE BIO-LOGIC PLAZA MUNDELEIN, IL 60060-3700 US Other 510(k) Applications for this Company
Contact	NORMAN E BRUNNER Other 510(k) Applications for this Contact
Regulation Number	882.1400   More FDA Info for this Regulation Number
Classification Product Code	OLV Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/30/2000
Decision Date	12/21/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review