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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 K202927
Device Name EYE-SYNC
Applicant
SyncThink, Inc.
2172 Staunton Court
Palo Alto,  CA  94306
Applicant Contact Dan Beeler
Correspondent
Arina Consulting, LLC
27 Hilltop Dr
San Carlos,  CA  94070
Correspondent Contact Allison Kumar
Regulation Number882.1455
Classification Product Code
QEA  
Subsequent Product Code
GWN  
Date Received09/29/2020
Decision Date 10/02/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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