FDA 510(k) Application Details - K200529

Device Classification Name	Apparatus, Vestibular Analysis   More FDA Info for this Device
510(K) Number	K200529
Device Name	Apparatus, Vestibular Analysis
Applicant	Interacoustics A/S Audiometer Alle 1 Middelfart DK-5500 DK Other 510(k) Applications for this Company
Contact	Erik Nielsen 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	03/02/2020
Decision Date	08/12/2020
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