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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 K180482
Device Name ZOLL Propaq M
Applicant
ZOLL Medical Corporation
269 & 271 Mill Road
Chelmsford,  MA  01824 -4105
Applicant Contact Pooja Dalvi
Correspondent
ZOLL Medical Corporation
269 & 271 Mill Road
Chelmsford,  MA  01824 -4105
Correspondent Contact Pooja Dalvi
Regulation Number870.1025
Classification Product Code
MHX  
Subsequent Product Codes
CCK   DPS   DQA   DRT   DSK  
DXN   FLL  
Date Received02/23/2018
Decision Date 11/30/2018
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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