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FDA 510(k) Application Details - K073147
Device Classification Name
Recorder,Event,Implantable Cardiac,(Without Arrhythmia Detection)
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510(K) Number
K073147
Device Name
Recorder,Event,Implantable Cardiac,(Without Arrhythmia Detection)
Applicant
TRANSOMA MEDICAL
4358 WEST ROUND LAKE RD.
ARDEN HILLS, MN 55112 US
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Contact
LISA STONE
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Regulation Number
870.2800
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Classification Product Code
MXC
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More FDA Info for this Product Code
Date Received
11/08/2007
Decision Date
12/03/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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