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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name display, diagnostic radiology
510(k) Number K140702
Device Name 8MP COLOR LCD MONITOR, RADIFORCE RX850
Applicant
EIZO CORPORATION
153 SHIMOKASHIWANO
HAKUSAN,  JP 924-8566
Applicant Contact HIROAKI HASHIMOTO
Correspondent
EIZO CORPORATION
153 SHIMOKASHIWANO
HAKUSAN,  JP 924-8566
Correspondent Contact HIROAKI HASHIMOTO
Regulation Number892.2050
Classification Product Code
PGY  
Date Received03/20/2014
Decision Date 04/04/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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