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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 K091561
Device Name ZOLL AED PLUS VERSION 5.32 SOFTWARE RELEASE
Applicant
ZOLL Medical Corporation
269 Mill Rd.
Chelsmford,  MA  01824
Applicant Contact CHARLES W KOLIFRATH
Correspondent
ZOLL Medical Corporation
269 Mill Rd.
Chelsmford,  MA  01824
Correspondent Contact CHARLES W KOLIFRATH
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received05/28/2009
Decision Date 09/23/2010
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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