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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 K081081
Device Name ZOLL E SERIES WITH BLUETOOTH DIAL UP NETWORKING
Applicant
Zoll Medical Corporation, World Wide Headquarters
269 Mill Rd.
Chelsmford,  MA  01824
Applicant Contact EILEEN M BOYLE
Correspondent
Zoll Medical Corporation, World Wide Headquarters
269 Mill Rd.
Chelsmford,  MA  01824
Correspondent Contact EILEEN M BOYLE
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received04/16/2008
Decision Date 03/09/2009
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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