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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 K083828
Device Name SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM -6 CM AND 8CM ANTENNA, PERSONAL DIAGNOSTICS MANAGER (PDM) ACCESSORY KIT
Applicant
Transoma
119 14th St. NW
St. Paul,  MN  55112
Applicant Contact LISA STONE
Correspondent
Transoma
119 14th St. NW
St. Paul,  MN  55112
Correspondent Contact LISA STONE
Regulation Number870.2800
Classification Product Code
MXC  
Date Received12/23/2008
Decision Date 02/11/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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