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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
Model VERISON 1.0
Device Name QT GUARD PLUS ANALYSIS SYSTEM
Original Applicant
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
9900 innovation drive
wauwatosa,  WI  53226
Original 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 (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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