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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 K071973
Device Name EPLEY OMNIAX
Applicant
Vesticon
2203 NE Oregon St.
Portland,  OR  97232
Applicant Contact CATHRYN EPLEY
Correspondent
Vesticon
2203 NE Oregon St.
Portland,  OR  97232
Correspondent Contact CATHRYN EPLEY
Classification Product Code
LXV  
Subsequent Product Code
GWN  
Date Received07/17/2007
Decision Date 06/20/2008
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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