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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 K192186
Device Name I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal Portable Assessment System - Nysragmograph
Applicant
Neurolign USA, LLC
128 Gamma Drive
Pittsburgh,  PA  15238
Applicant Contact Aura Kullmann
Correspondent
Neurolign USA, LLC
128 Gamma Drive
Pittsburgh,  PA  15238
Correspondent Contact Aura Kullmann
Regulation Number882.1460
Classification Product Code
GWN  
Date Received08/12/2019
Decision Date 11/29/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Clinical Trials NCT01832714
NCT02486003
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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