FDA 510(k) Application Details - K042007

Device Classification Name Automated External Defibrillators (Non-Wearable)

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510(K) Number K042007
Device Name Automated External Defibrillators (Non-Wearable)
Applicant ZOLL MEDICAL CORP.
269 MILL ROAD
CHELMSFORD, MA 01824-4105 US
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Contact SEAN REYNOLDS
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Regulation Number 870.5310

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Classification Product Code MKJ
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Date Received 07/26/2004
Decision Date 04/07/2005
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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