FDA 510(k) Application Details - K012384

Device Classification Name	Device, Biofeedback   More FDA Info for this Device
510(K) Number	K012384
Device Name	Device, Biofeedback
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	882.5050   More FDA Info for this Regulation Number
Classification Product Code	HCC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/27/2001
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