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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 K122550
FOIA Releasable 510(k) K122550
Device Name ICS IMPULSE
Applicant
Gn Otometrics
8870 Ravello Ct.
Naples,  FL  34114
Applicant Contact DANIEL KAMM
Correspondent
Gn Otometrics
8870 Ravello Ct.
Naples,  FL  34114
Correspondent Contact DANIEL KAMM
Regulation Number882.1460
Classification Product Code
GWN  
Subsequent Product Code
LXV  
Date Received08/21/2012
Decision Date 02/01/2013
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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