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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 K081365
Device Name SJM CONFIRM MODEL DM2100 IMPLANTABLE CARDIAC MONITOR AND MODEL DM2100A PATIENT ACTIVATOR
Applicant
ST. JUDE MEDICAL
701 EAST EVELYN AVENUE
SUNNYVALE,  CA  94086 -6527
Applicant Contact ELIZABETH E NEELY
Correspondent
ST. JUDE MEDICAL
701 EAST EVELYN AVENUE
SUNNYVALE,  CA  94086 -6527
Correspondent Contact ELIZABETH E NEELY
Regulation Number870.2800
Classification Product Code
MXC  
Subsequent Product Codes
DSH   DXH  
Date Received05/15/2008
Decision Date 08/15/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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