FDA 510(k) Application Details - K013515

Device Classification Name Display, Cathode-Ray Tube, Medical

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510(K) Number K013515
Device Name Display, Cathode-Ray Tube, Medical
Applicant SIEMENS MEDICAL SOLUTIONS USA, INC.
16 ELECTRONICS AVE.
DANVERS, MA 01923 US
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Contact PENELOPE H GRECO
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Regulation Number 870.2450

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Classification Product Code DXJ
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Date Received 10/22/2001
Decision Date 01/10/2002
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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