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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 K152915
Device Name EYE-SYNC
SyncThink, Inc.
54 Canal Street Suite 200
Boston,  MA  02114
Applicant Contact Daniel Beeler
O'Connell Regulatory Consultants, Inc.
5 Timber Lane
North Reading,  MA  01864
Correspondent Contact Maureen O'Connell
Regulation Number882.1460
Classification Product Code
Date Received10/02/2015
Decision Date 01/29/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No