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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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More FDA Info for this Product Code
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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