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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name display, cathode-ray tube, medical
510(k) Number K122167
Device Name NEXXIS OR
Original Applicant
BARCO NV
35 president kennedypark
kortrijk,  BE 8500
Original Contact lieven de wandel
Regulation Number870.2450
Classification Product Code
DXJ  
Date Received08/24/2012
Decision Date 04/22/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
statement statement
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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