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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 K083332
Device Name MD21M 21.3 DIAGNOSTIC IMAGING LCD MONITOR, MODEL L218TK
Applicant
Nec Display Solutions , Ltd.
1f, # 181, Sec. 2 Wunhua
1st Rd., Linkou Township
Taipe,  TW 244
Applicant Contact ANGUS HSU
Correspondent
Nec Display Solutions , Ltd.
1f, # 181, Sec. 2 Wunhua
1st Rd., Linkou Township
Taipe,  TW 244
Correspondent Contact ANGUS HSU
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received11/12/2008
Decision Date 01/09/2009
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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