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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 K083603
Device Name I-PORTAL 4D VIDEO OCULOGRAPHY EYE TRACKING SYSTEM (VOG), I-PORTAL VIDEO NYSTAGMOGRAPHY SYSTEM (VNG), I-PORTAL NEURO OTOL
Applicant
NEURO KINETICS
128 GAMMA DR.
PITTSBURGH,  PA  15238
Applicant Contact Aura Kullmann
Correspondent
NEURO KINETICS
128 GAMMA DR.
PITTSBURGH,  PA  15238
Correspondent Contact Aura Kullmann
Regulation Number882.1460
Classification Product Code
GWN  
Date Received12/05/2008
Decision Date 08/06/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Ear Nose & Throat
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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