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510(k) K063035

SLEUTH IMPLANTABLE ECG MONITORING SYSTEM by Transnoma Medical, Inc. — Product Code MXC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 1, 2007
Date Received
September 29, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)
Device Class
Class II
Regulation Number
870.2800
Review Panel
CV
Submission Type

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