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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 K030347
Device Name 20.1 MONOCHROME LCD MONITOR, RADIFORCE G20
Applicant
Eizo Nanao Corporation
319 Akeno Obata-Cho
Watarai-Gun, Mie-Ken,  JP 519-05
Applicant Contact AKIRA WAKAYAMA
Correspondent
Eizo Nanao Corporation
319 Akeno Obata-Cho
Watarai-Gun, Mie-Ken,  JP 519-05
Correspondent Contact AKIRA WAKAYAMA
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received02/03/2003
Decision Date 05/02/2003
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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