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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 K212310
Device Name EyeBOX (Model EBX-4)
Applicant
Oculogica, Inc.
33 Irving Place
New York,  NY  10003
Applicant Contact Rosina Samadani
Correspondent
Hogan Lovells US LLP
1735 Market Street, Suite 2300
Philadelphia,  PA  19103
Correspondent Contact Janice Hogan
Regulation Number882.1455
Classification Product Code
QEA  
Date Received07/23/2021
Decision Date 12/22/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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