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510(k) K091206

SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM-6 AND 8CM ANTENNA, PERSONAL DIAGNOSTIC MANAGER(PDM) ACCESSORY KIT, MODEL by Transoma Medical — Product Code MXC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 18, 2009
Date Received
April 24, 2009
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

  • K073147 — SLEUTH IMPLANTABLE ECG SYSTEM-8 CM ACCESSORY KIT, MODEL 3000-08 (December 3, 2007)

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