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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 K120301
Model MG1000
Device Name MEDIGUIDE TECHNOLOGY
Applicant
ST. JUDE MEDICAL, MEDIGUIDE NAVIGATION SYSTEMS
columbia square
555 thirteenth, nw
washington,  DC  20004 1109
Contact jonathan s kahan
Regulation Number870.1425
Classification Product Code
DQK  
Date Received01/31/2012
Decision Date 02/24/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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