FDA 510(k) Application Details - K111905

Device Classification Name Display, Cathode-Ray Tube, Medical

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510(K) Number K111905
Device Name Display, Cathode-Ray Tube, Medical
Applicant PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN
HEWLETT-PACKARD STR.2
BOEBLINGEN D 71034 DE
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Contact MARKUS STACHA
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Regulation Number 870.2450

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Classification Product Code DXJ
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Date Received 07/05/2011
Decision Date 10/04/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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