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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name monitor, physiological, patient(with arrhythmia detection or alarms)
510(k) Number K121367
Device Name ZOLL PROPAQ XM
Applicant
ZOLL MEDICAL CORPORATION
269 MILL ROAD
CHELMSFORD,  MA  01824 -4105
Applicant Contact CHARLES W KOLIFRATH
Correspondent
ZOLL MEDICAL CORPORATION
269 MILL ROAD
CHELMSFORD,  MA  01824 -4105
Correspondent Contact CHARLES W KOLIFRATH
Regulation Number870.1025
Classification Product Code
MHX  
Subsequent Product Codes
CCK   DPS   DQA   DXN   FLL  
Date Received05/07/2012
Decision Date 06/21/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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