FDA 510(k) Application Details - K133994

Device Classification Name Display, Cathode-Ray Tube, Medical

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510(K) Number K133994
Device Name Display, Cathode-Ray Tube, Medical
Applicant BARCO N.V.
35 PRESIDENT KENNEDYPARK
KORTRIJK 8500 BE
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Contact LIEVEN DE WANDEL
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Regulation Number 870.2450

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Classification Product Code DXJ
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Date Received 12/26/2013
Decision Date 12/01/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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