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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 K141774
Device Name ZOLL X SERIES
Applicant
ZOLL MEDICAL CORPORATION
269 MILL ROAD
chelmsford,  MA  01824 -4105
Applicant Contact tammay shukla
Correspondent
ZOLL MEDICAL CORPORATION
269 MILL ROAD
chelmsford,  MA  01824 -4105
Correspondent Contact tammay shukla
Regulation Number870.5310
Classification Product Code
MKJ  
Subsequent Product Codes
CCK   DQA   DRO   DRT   DSK  
DXN   LDD   LIX  
Date Received07/02/2014
Decision Date 11/19/2014
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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