FDA 510(k) Application Details - K173669

Device Classification Name	Apparatus, Vestibular Analysis   More FDA Info for this Device
510(K) Number	K173669
Device Name	Apparatus, Vestibular Analysis
Applicant	King-Devick Technologies, Inc. Two Mid America Plaza Suite 110 Oakbrook Terrace, IL 60181 US Other 510(k) Applications for this Company
Contact	Lori Grover Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LXV Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/30/2017
Decision Date	04/02/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review