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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 K171884
Device Name I-Portal Portable Assessment System - Nystagmograph (I-PAS)
Applicant
Neuro Kinetics, Inc.
128 Gamma Dr.
Pittsburgh,  PA  15238
Applicant Contact Brian Sullivan
Correspondent
Neuro Kinetics, Inc.
128 Gamma Dr.
Pittsburgh,  PA  15238
Correspondent Contact Brian Sullivan
Regulation Number882.1460
Classification Product Code
GWN  
Date Received06/23/2017
Decision Date 11/22/2017
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
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