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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 K131295
Device Name NIO COLOR 3MP LED
Applicant
Barco N.V.
35 President Kennedypark
Kortrijk,  BE
Applicant Contact LIEVEN DE WANDEL
Correspondent
Barco N.V.
35 President Kennedypark
Kortrijk,  BE
Correspondent Contact LIEVEN DE WANDEL
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received05/06/2013
Decision Date 05/29/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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