FDA 510(k) Application Details - K171384

Device Classification Name	Electroencephalograph   More FDA Info for this Device
510(K) Number	K171384
Device Name	Electroencephalograph
Applicant	Micromed S.P.A Via Giotto 2 Mogliano Veneto 31021 IT Other 510(k) Applications for this Company
Contact	Monica Camillo 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	05/11/2017
Decision Date	02/01/2018
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