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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph
510(k) Number K120770
Device Name QT GUARD PLUS ANALYSIS SYSTEM
Applicant
Ge Medical Systems Information Technologies
9900 Innovation Dr.
Wauwatosa,  WI  53226
Applicant Contact KRISTIN PABST
Correspondent
Ge Medical Systems Information Technologies
9900 Innovation Dr.
Wauwatosa,  WI  53226
Correspondent Contact KRISTIN PABST
Regulation Number870.2340
Classification Product Code
DPS  
Subsequent Product Code
MLC  
Date Received03/14/2012
Decision Date 12/06/2012
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
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