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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 K143607
Device Name I-Portal NOTC, VNG and VOG
Applicant
NEURO KINETICS, INC.
128 GAMMA DRIVE
PITTSBURGH,  PA  15238
Applicant Contact J. Howison Schroeder
Correspondent
NEURO KINETICS, INC.
128 GAMMA DRIVE
PITTSBURGH,  PA  15238
Correspondent Contact J. Howison Schroeder
Regulation Number882.1460
Classification Product Code
GWN  
Date Received12/19/2014
Decision Date 07/08/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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