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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 K083907
Device Name MD212MC 21.3 DIAGNOSTIC IMAGING LCD MONITOR-L217TG
Applicant
Nec Display Solutions , Ltd.
1f, # 181, Sec. 2 Wunhua
1st Rd., Linkou Township
Taipe,  TW 244
Applicant Contact ANGUS HSU
Correspondent
Underwriters Laboratories, Inc.
2600 NW Lake Rd.
Camas,  WA  98607
Correspondent Contact MARC M MOUSER
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received12/30/2008
Decision Date 01/13/2009
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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