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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 K063035
Device Name SLEUTH IMPLANTABLE ECG MONITORING SYSTEM
Applicant
Transnoma Medical, Inc.
4358 W. Round Lake Rd.
Arden Hills,  MN  55112
Applicant Contact ANGELA RAUN
Correspondent
Transnoma Medical, Inc.
4358 W. Round Lake Rd.
Arden Hills,  MN  55112
Correspondent Contact ANGELA RAUN
Regulation Number870.2800
Classification Product Code
MXC  
Date Received09/29/2006
Decision Date 10/01/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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