FDA 510(k) Application Details - K110967

Device Classification Name	Reduced- Montage Standard Electroencephalograph   More FDA Info for this Device
510(K) Number	K110967
Device Name	Reduced- Montage Standard Electroencephalograph
Applicant	NEURALYNX INC 105 COMMERCIAL DRIVE BOZEMAN, MT 59715-2217 US Other 510(k) Applications for this Company
Contact	MIKE JOHNSON 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	04/06/2011
Decision Date	06/30/2011
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