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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
Model 1085
Device Name ICS IMPULSE
Original Applicant
GN OTOMETRICS
8870 ravello ct
naples,  FL  34114
Original 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 (SE)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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