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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid
510(k) Number K191183
Device Name EyeBOX
Applicant
Oculogica, Inc.
33 Irving Place
New York,  NY  10003
Applicant Contact Rosina Samadani
Correspondent
Oculogica, Inc.
33 Irving Place
New York,  NY  10003
Correspondent Contact Rosina Samadani
Regulation Number882.1455
Classification Product Code
QEA  
Date Received05/02/2019
Decision Date 07/31/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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