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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name display, cathode-ray tube, medical
510(k) Number K131919
Device Name ZOLL EPCR IOS
Applicant
ZOLL MEDICAL CORPORATION
269 MILL ROAD
CHELMSFORD,  MA  01824 -4105
Applicant Contact SHANNON DUHAMEL
Correspondent
ZOLL MEDICAL CORPORATION
269 MILL ROAD
CHELMSFORD,  MA  01824 -4105
Correspondent Contact SHANNON DUHAMEL
Regulation Number870.2450
Classification Product Code
DXJ  
Subsequent Product Code
NSX  
Date Received06/26/2013
Decision Date 12/17/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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