FDA 510(k) Application Details - K151504

Device Classification Name	Nystagmograph   More FDA Info for this Device
510(K) Number	K151504
Device Name	Nystagmograph
Applicant	GN OTOMETRICS HOERSKAETTEN 9 TAATRUP DK-2630 DK Other 510(k) Applications for this Company
Contact	ANDERS RASMUSSEN 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	06/04/2015
Decision Date	11/16/2015
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