FDA 510(k) Application Details - K161880

Device Classification Name Display, Cathode-Ray Tube, Medical

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510(K) Number K161880
Device Name Display, Cathode-Ray Tube, Medical
Applicant Barco N.V.
President Kennedypark 35
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 07/08/2016
Decision Date 03/14/2017
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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