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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name recorder,event,implantable cardiac,(without arrhythmia detection)
510(k) Number K122161
Model DM2100
Device Name SJM CONFIRM
Original Applicant
ST. JUDE MEDICAL
701 east evelyn avenue
sunnyvale,  CA  94086 6527
Original Contact saket bhatt
Regulation Number870.2800
Classification Product Code
MXC  
Date Received07/20/2012
Decision Date 11/28/2012
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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