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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 K133239
Device Name ZOLL E SERIES
Applicant
Zoll Medical Corporation, World Wide Headquarters
269 Mill Rd.
Chelmsford,  MA  01824 -4105
Applicant Contact TANMAY B SHUKLA
Correspondent
Zoll Medical Corporation, World Wide Headquarters
269 Mill Rd.
Chelmsford,  MA  01824 -4105
Correspondent Contact TANMAY B SHUKLA
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received10/21/2013
Decision Date 01/16/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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