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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 K151504
Device Name ICS Impulse
Applicant
Gn Otometrics
Hoerskaetten 9
Taastrup,  DK DK-2630
Applicant Contact ANDERS RASMUSSEN
Correspondent
Kamm & Associates
8870 Ravello Ct.
Naples,  FL  34114
Correspondent Contact DANIEL KAMM
Regulation Number882.1460
Classification Product Code
GWN  
Date Received06/04/2015
Decision Date 11/16/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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