FDA 510(k) Application Details - K110742

Device Classification Name Automated External Defibrillators (Non-Wearable)

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510(K) Number K110742
Device Name Automated External Defibrillators (Non-Wearable)
Applicant ZOLL MEDICAL CORPORATION
525 NARRAGANSETT PARK DRIVE
PAWTUCKET, RI 02861 US
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Contact ROBERT MORSE
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Regulation Number 870.5310

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Classification Product Code MKJ
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Date Received 03/17/2011
Decision Date 04/13/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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