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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K130772
Device Name MD211C2 21.3 DIAGNOSTIC IMAGING LCD MONITOR
Applicant
Nec Display Solutions , Ltd.
1f, # 181, S. 2, Wunhua 1st Rd.
Linkou Township
Taipei,  TW 24447
Applicant Contact ANGUS HSU
Correspondent
Underwriters Laboratories, Inc.
12 Laboratory Dr.
Research Triangel Park,  NC  27709
Correspondent Contact JEFFREY D RONGERO
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received03/20/2013
Decision Date 04/18/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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