FDA 510(k) Application Details - K141774

Device Classification Name Automated External Defibrillators (Non-Wearable)

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510(K) Number K141774
Device Name Automated External Defibrillators (Non-Wearable)
Applicant ZOLL MEDICAL CORPORATION
269 MILL ROAD
CHELMSFORD, MA 01824-4105 US
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Contact TAMMAY SHUKLA
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Regulation Number 870.5310

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Classification Product Code MKJ
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Date Received 07/02/2014
Decision Date 11/19/2014
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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