FDA 510(k) Application Details - K081602

Device Classification Name	Apparatus, Vestibular Analysis   More FDA Info for this Device
510(K) Number	K081602
Device Name	Apparatus, Vestibular Analysis
Applicant	CLEARWATER CLINICAL LIMITED 100-111 5TH AVE. SW SUITE 258 CALGARY, ALBERTA T2P 3Y6 CA Other 510(k) Applications for this Company
Contact	MATTHEW BROMWICH 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	06/06/2008
Decision Date	09/19/2008
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