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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 K132488
Device Name ZOLL CODE WRITER
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 Received08/08/2013
Decision Date 04/03/2014
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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