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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 K163270
Device Name ISEN-Goggles with Data Viewer
Applicant
Isent Tech & Trading Company, Ltd.
Rm509, Bldg. A, Cybertower, #2 Zhongguancun S Ave.
Beijing,  CN 100086
Applicant Contact MARTIN LIU
Correspondent
Vision28
915 SW Rimrock Way
Suite 201 Pmb 402
Remond,  OR  97756
Correspondent Contact TIM RENNER
Regulation Number882.1460
Classification Product Code
GWN  
Date Received11/21/2016
Decision Date 09/25/2017
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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