FDA 510(k) Application Details - K163558

Device Classification Name	Nystagmograph   More FDA Info for this Device
510(K) Number	K163558
Device Name	Nystagmograph
Applicant	Synapsys SA Marseille 13013 FR Other 510(k) Applications for this Company
Contact	Laetitia Baconnier 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	12/19/2016
Decision Date	03/23/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review