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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Vestibular Analysis
510(k) Number K082634
Device Name VERTIGONE BPPV GOGGLE
Applicant
Vertigone, Inc.
2202 Timberloch Pl.
Suite 230
Woodlands,  TX  77380
Applicant Contact JAYE THOMPSON
Correspondent
Vertigone, Inc.
2202 Timberloch Pl.
Suite 230
Woodlands,  TX  77380
Correspondent Contact JAYE THOMPSON
Classification Product Code
LXV  
Date Received09/10/2008
Decision Date 04/07/2009
Decision Substantially Equivalent (SESE)
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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