FDA 510(k) Application Details - K190735

Device Classification Name	Apparatus, Vestibular Analysis   More FDA Info for this Device
510(K) Number	K190735
Device Name	Apparatus, Vestibular Analysis
Applicant	Highmark Innovations Inc. DBA Highmark Interactive 1 University Avenue, 3rd Floor Toronto M5J 2Pl CA Other 510(k) Applications for this Company
Contact	Dave Crane 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	03/21/2019
Decision Date	08/16/2019
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