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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 K080903
Device Name ZOLL E SERIES WITH INTIBATION ASSIST OPTION
Applicant
ZOLL MEDICAL CORPORATION
269 MILL ROAD
CHELMSFORD,  MA  01824 -4105
Applicant Contact EILEEN M BOYLE
Correspondent
ZOLL MEDICAL CORPORATION
269 MILL ROAD
CHELMSFORD,  MA  01824 -4105
Correspondent Contact EILEEN M BOYLE
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received04/01/2008
Decision Date 12/04/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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