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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 K181025
Device Name I-Portal Neuro Otologic Test Center; I-Portal Video Nystagmography System; I-Portal Video Oculography Eye Tracking System
Applicant
Neuro Kinetics, Inc.
128 Gamma Dr.
Pittsburgh,  PA  15238
Applicant Contact Robin C. Ashmore
Correspondent
Neuro Kinetics, Inc.
128 Gamma Dr.
Pittsburgh,  PA  15238
Correspondent Contact Robin C. Ashmore
Regulation Number882.1460
Classification Product Code
GWN  
Date Received04/18/2018
Decision Date 07/24/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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