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510(k) K073147

SLEUTH IMPLANTABLE ECG SYSTEM-8 CM ACCESSORY KIT, MODEL 3000-08 by Transoma Medical — Product Code MXC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 2007
Date Received
November 8, 2007
Clearance Type
Special
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

Other clearances by Transoma Medical

  • K091206 — SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM-6 AND 8CM ANTENNA, PERSONAL DIAG (May 18, 2009)

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