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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nystagmograph
510(k) Number K061791
Device Name FOCUS VNG/ENG TYPE 1068
Applicant
Gn Otometrics A/S
125 Commerce Dr.
Schaumburg,  IL  60173
Applicant Contact MICHAEL HAMACHER
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Correspondent Contact DANIEL W LEHTONEN
Regulation Number882.1460
Classification Product Code
GWN  
Date Received06/26/2006
Decision Date 07/11/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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