FDA 510(k) Application Details - K032691

Device Classification Name Dc-Defibrillator, Low-Energy, (Including Paddles)

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510(K) Number K032691
Device Name Dc-Defibrillator, Low-Energy, (Including Paddles)
Applicant ZOLL MEDICAL CORP.
269 MILL ROAD
CHELMSFORD, MA 01824-4105 US
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Contact PAUL DIAS
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Regulation Number 870.5300

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Classification Product Code LDD
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Date Received 09/02/2003
Decision Date 11/13/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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