FDA 510(k) Application Details - K032439

Device Classification Name Automated External Defibrillators (Non-Wearable)

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510(K) Number K032439
Device Name Automated External Defibrillators (Non-Wearable)
Applicant ZOLL MEDICAL CORP.
269 MILL ROAD
CHELMSFORD, MA 01824-4105 US
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Contact SCOTT AUGUST
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Regulation Number 870.5310

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Classification Product Code MKJ
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Date Received 08/07/2003
Decision Date 11/05/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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