FDA 510(k) Application Details - K162681

Device Classification Name	Electroencephalograph   More FDA Info for this Device
510(K) Number	K162681
Device Name	Electroencephalograph
Applicant	Neuroelectrics Barcelona S.L.U. Avenida Tibidabo 47 bis Barcelona 08035 ES Other 510(k) Applications for this Company
Contact	Anna Maiques 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	09/26/2016
Decision Date	06/02/2017
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