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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 K081357
Device Name 5MP GRAYSCALE FLAT PANEL DISPLAY, MODEL, 6GF6201-5C$2# (WHERE $ = A-Z AND # = 0-9)
Applicant
Eizo GmbH
Siemensallee 84
Karlsruhe,  DE 76187
Applicant Contact JAMES BERGE
Correspondent
Eizo GmbH
Siemensallee 84
Karlsruhe,  DE 76187
Correspondent Contact JAMES BERGE
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received05/14/2008
Decision Date 09/05/2008
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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