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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 K110526
Device Name ZOLL AEDPRO WITH 2010 AHA GUIDELINES SOFTWARE UPDATE
Applicant
ZOLL Medical Corporation
269 Mill Rd.
Chelsmford,  MA  01824
Applicant Contact EILEEN M BOYLE
Correspondent
ZOLL Medical Corporation
269 Mill Rd.
Chelsmford,  MA  01824
Correspondent Contact EILEEN M BOYLE
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received02/24/2011
Decision Date 03/25/2011
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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