FDA 510(k) Application Details - K122196

Device Classification Name	Electroencephalograph   More FDA Info for this Device
510(K) Number	K122196
Device Name	Electroencephalograph
Applicant	BLACKROCK NEUROMED, LLC 117 WEST SOUTH STREET OCONOMOWOC, WI 53066 US Other 510(k) Applications for this Company
Contact	JOHN ZIOBRO 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	07/24/2012
Decision Date	05/02/2013
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