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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 K120451
Model RX840
Device Name 8MP COLOR LCD MONITOR, REDIFORCE RX840
Applicant
EIZO NANAO CORPORATION
153 shimokashiwano
hakusan, 
Contact hiroaki hashimoto
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received02/14/2012
Decision Date 08/03/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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