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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name computer, diagnostic, programmable
510(K) Number K113515
Device Name HORIZON CARDIOLOGY ECG MANAGEMENT
Applicant
MCKESSON ISRAEL LTD.
hanechoshet 4
tel aviv, 
Contact tomer levy
Regulation Number870.1425
Classification Product Code
DQK  
Date Received11/28/2011
Decision Date 03/16/2012
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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