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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Display, Diagnostic Radiology
510(k) Number K170944
Device Name LCD Monitor (MD310C, MD310G, MD210G)
Applicant
BenQ Corporation
16 Jihu Road, Neihu
Taipei,  TW 114
Applicant Contact Calvin KT Chang
Correspondent
BenQ Corporation
16 Jihu Road, Neihu
Taipei,  TW 114
Correspondent Contact Calvin KT Chang
Regulation Number892.2050
Classification Product Code
PGY  
Date Received03/30/2017
Decision Date 05/25/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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