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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, network and communication, physiological monitors
510(k) Number K111296
Device Name ZOLL RESCUENETLINK
Applicant
ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS
269 MILL ROAD
CHELMSFORD,  MA  01824 -4105
Applicant Contact CHARLES W KOLIFRATH
Correspondent
ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS
269 MILL ROAD
CHELMSFORD,  MA  01824 -4105
Correspondent Contact CHARLES W KOLIFRATH
Regulation Number870.2300
Classification Product Code
MSX  
Date Received05/09/2011
Decision Date 10/27/2011
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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