FDA 510(k) Application Details - K123255

Device Classification Name	Amplifier, Physiological Signal   More FDA Info for this Device
510(K) Number	K123255
Device Name	Amplifier, Physiological Signal
Applicant	G.TEC MEDICAL ENGINEERING GMBH SIERNINGSTRASSE 14 SCHIEDLBERG 4521 AT Other 510(k) Applications for this Company
Contact	CHRISTOPH GUGER Other 510(k) Applications for this Contact
Regulation Number	882.1835   More FDA Info for this Regulation Number
Classification Product Code	GWL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/18/2012
Decision Date	12/20/2012
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	Y
Expedited Review