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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
Original Applicant
ZOLL MEDICAL CORPORATION
269 mill road
chelmsford,  MA  01824 -4105
Original 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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