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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
510(k) Number K102174
Device Name ZOLL PROPAQ M
Applicant
Zoll Medical Corporation, World Wide Headquarters
269 Mill Rd.
Chelmsford,  MA  01824 -4105
Applicant Contact PAUL DIAS
Correspondent
Zoll Medical Corporation, World Wide Headquarters
269 Mill Rd.
Chelmsford,  MA  01824 -4105
Correspondent Contact PAUL DIAS
Regulation Number870.2300
Classification Product Code
DRT  
Subsequent Product Codes
CCK   DQA   DSK   DXN  
Date Received08/02/2010
Decision Date 09/15/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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