FDA 510(k) Application Details - K172312

Device Classification Name	Amplifier, Physiological Signal   More FDA Info for this Device
510(K) Number	K172312
Device Name	Amplifier, Physiological Signal
Applicant	eemagine Medical Imaging Solutions GmbH Gubenerstr. 47, Fabrik D-10243 Berlin DE Other 510(k) Applications for this Company
Contact	Frank Zanow 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	08/01/2017
Decision Date	03/30/2018
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