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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated External Defibrillators (Non-Wearable)
510(k) Number K042007
Device Name ZOLL E SERIES DEFIBRILLATOR
Applicant
ZOLL MEDICAL CORP.
269 MILL ROAD
CHELMSFORD,  MA  01824 -4105
Applicant Contact SEAN REYNOLDS
Correspondent
ZOLL MEDICAL CORP.
269 MILL ROAD
CHELMSFORD,  MA  01824 -4105
Correspondent Contact SEAN REYNOLDS
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received07/26/2004
Decision Date 04/07/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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