FDA 510(k) Application Details - K163149

Device Classification Name	Nystagmograph   More FDA Info for this Device
510(K) Number	K163149
Device Name	Nystagmograph
Applicant	Interacoustics A/S Audiometer Alle 1 Middelfart 5500 DK Other 510(k) Applications for this Company
Contact	Erik Nielsen Other 510(k) Applications for this Contact
Regulation Number	882.1460   More FDA Info for this Regulation Number
Classification Product Code	GWN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/09/2016
Decision Date	04/26/2017
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