FDA 510(k) Application Details - K151736

Device Classification Name Display, Cathode-Ray Tube, Medical

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510(K) Number K151736
Device Name Display, Cathode-Ray Tube, Medical
Applicant PHILIPS MEDIZIN SYSTEME BOBLINGEN GMBH
HEWLETT-PACKARD-STR. 2
BOBLINGEN 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 06/26/2015
Decision Date 10/21/2015
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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