FDA 510(k) Application Details - K130013

Device Classification Name	Reduced- Montage Standard Electroencephalograph   More FDA Info for this Device
510(K) Number	K130013
Device Name	Reduced- Montage Standard Electroencephalograph
Applicant	ADVANCED BRAIN MONITORING INC. W324 S3649 COUNTY ROAD E DOUSMAN, WI 53118 US Other 510(k) Applications for this Company
Contact	ADRIENNE LENZ Other 510(k) Applications for this Contact
Regulation Number	882.1400   More FDA Info for this Regulation Number
Classification Product Code	OMC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/02/2013
Decision Date	01/31/2013
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