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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
Recalls CDRH Recalls
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