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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 Rd.
Chelsmford,  MA  01824
Applicant Contact Pooja Dalvi
Correspondent
ZOLL Medical Corporation
269 & 271 Mill Rd.
Chelsmford,  MA  01824
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
Predetermined Change
Control Plan Authorized		 No
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