FDA 510(k) Application Details - K161767

Device Classification Name Display, Cathode-Ray Tube, Medical

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510(K) Number K161767
Device Name Display, Cathode-Ray Tube, Medical
Applicant PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH
HEWLETT-PACKARD STR. 2
BOEBLINGEN 71034 DE
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Contact Michael Asmalsky
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Regulation Number 870.2450

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Classification Product Code DXJ
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Date Received 06/27/2016
Decision Date 01/27/2017
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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