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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
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