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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 K152727
Device Name ISEN-Goggles
Applicant
Isen Tech & Trading Company, Ltd.
Rm509, Bldg. A, Cyber Tower, # 2 Zhongguancun S. Ave.
Beijing,  CN 100086
Applicant Contact MARTIN LIU
Correspondent
Bovard Consulting, LLC
378 Hardy Ave.
Eugene,  OR  97404
Correspondent Contact LINDA J BOVARD
Regulation Number882.1460
Classification Product Code
GWN  
Date Received09/22/2015
Decision Date 04/26/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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