FDA 510(k) Application Details - K130201

Device Classification Name	Nystagmograph   More FDA Info for this Device
510(K) Number	K130201
Device Name	Nystagmograph
Applicant	OTOTRONIX, LLC 4486 TIMBERLINE CT ST PAUL, MN 55127 US Other 510(k) Applications for this Company
Contact	BERNARD HORWATH 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	01/28/2013
Decision Date	04/26/2013
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