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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 K120907
Device Name ZOLL R SERIES
Applicant
ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS
269 MILL ROAD
CHELMSFORD,  MA  01824 -4105
Applicant Contact CHARLES W KOLIFRATH
Correspondent
ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS
269 MILL ROAD
CHELMSFORD,  MA  01824 -4105
Correspondent Contact CHARLES W KOLIFRATH
Regulation Number870.5310
Classification Product Code
MKJ  
Subsequent Product Codes
CCK   DQA   DRO   DRT   DXN  
LDD   LIX  
Date Received03/26/2012
Decision Date 09/25/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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