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510(k) K081365

SJM CONFIRM MODEL DM2100 IMPLANTABLE CARDIAC MONITOR AND MODEL DM2100A PATIENT ACTIVATOR by St Jude Medical — Product Code MXC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 2008
Date Received
May 15, 2008
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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