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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive
510(k) Number K032363
Device Name ZOLL M SERIES NIBP OPTION
Applicant
Zoll Medical Corp
269 Mill Rd.
Chelmsford,  MA  01824 -4105
Applicant Contact SEAN REYNOLDS
Correspondent
Zoll Medical Corp
269 Mill Rd.
Chelmsford,  MA  01824 -4105
Correspondent Contact SEAN REYNOLDS
Regulation Number870.1130
Classification Product Code
DXN  
Date Received07/31/2003
Decision Date 10/31/2003
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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