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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 K254086
Device Name EyeBOX SNAP
Applicant
Oculogica, Inc.
1477 S. Knowles Ave.
#110f
New Richmond,  WI  54017
Applicant Contact Rosina Samadani
Correspondent
Hogan Lovells
1735 Market St., Suite 2300
Philadelphia,  PA  19103
Correspondent Contact Janice Hogan
Regulation Number882.1455
Classification Product Code
QEA  
Date Received12/18/2025
Decision Date 06/05/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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