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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 K052942
Device Name 21.3INCH MONOCHROME LCD MONITOR
Applicant
Nec-Mitsubishi Electric Visual Systems Corp.
4-13-23 Shibaura
Minato-Ku, Tokyo,  JP 108-0023
Applicant Contact SHUICHI KINO
Correspondent
Tuv Rheinland of North America, Inc.
12 Commerce Rd.
Newton,  CT  06470
Correspondent Contact TAMAS BORSAI
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received10/20/2005
Decision Date 12/27/2005
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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