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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
35 president kennedypark
kortrijk,  BE 8500
Original Contact lieven de wandel
Regulation Number870.2450
Classification Product Code
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