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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 K121865
Model RESCUENET 12-LEAD
Device Name ZOLL RESCUENET 12-LEAD
Original Applicant
ZOLL MEDICAL CORPORATION
269 mill road
chelmsford,  MA  01824
Original Contact charles w kolifrath
Regulation Number870.2300
Classification Product Code
MSX  
Date Received06/26/2012
Decision Date 11/20/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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