FDA 510(k) Application Details - K103473

Device Classification Name Display, Cathode-Ray Tube, Medical

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510(K) Number K103473
Device Name Display, Cathode-Ray Tube, Medical
Applicant ZOLL MEDICAL CORPORATION
269 MILL ROAD
CHELMSFORD, MA 01824-4105 US
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Contact CHARLES W KOLIFRATH
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Regulation Number 870.2450

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Classification Product Code DXJ
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Date Received 11/24/2010
Decision Date 05/13/2011
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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