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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 K133534
Device Name MCKESSON CARDIOLOGY ECG MOBILE
Applicant
Mckesson Israel , Ltd.
5995 Windward Pkwy.
Alpharetta,  GA  30005
Applicant Contact PAUL SUMNER
Correspondent
Mckesson Israel , Ltd.
5995 Windward Pkwy.
Alpharetta,  GA  30005
Correspondent Contact PAUL SUMNER
Regulation Number870.1425
Classification Product Code
DQK  
Date Received11/18/2013
Decision Date 04/18/2014
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
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