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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 (without arrhythmia detection or alarms)
510(k) Number K202375
Device Name ZOLL Propaq M
Applicant
ZOLL Medical Corporation
269 Mill Road
Chelmsford,  MA  01824
Applicant Contact Elizabeth McMeniman
Correspondent
ZOLL Medical Corporation
269 Mill Road
Chelmsford,  MA  01824
Correspondent Contact Elizabeth McMeniman
Regulation Number870.2300
Classification Product Code
MWI  
Subsequent Product Codes
CCK   DPS   DQA   DRT   DSK  
DXN   FLL  
Date Received08/20/2020
Decision Date 03/09/2021
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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