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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 ROAD
CHELMSFORD,  MA  01824 -4105
Applicant Contact SEAN REYNOLDS
Correspondent
ZOLL MEDICAL CORP.
269 MILL ROAD
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
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