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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,  IL 69710
Applicant Contact TOMER LEVY
Correspondent
Mckesson Israel , Ltd.
Hanechoshet 4
Tel Aviv,  IL 69710
Correspondent Contact TOMER LEVY
Regulation Number870.1425
Classification Product Code
DQK  
Date Received11/28/2011
Decision Date 03/16/2012
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
Recalls CDRH Recalls
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