FDA 510(k) Application Details - K093288

Device Classification Name Detector And Alarm, Arrhythmia

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510(K) Number K093288
Device Name Detector And Alarm, Arrhythmia
Applicant CARDIONET, INC
1010 2ND AVE., SUITE 700
SAN DIEGO, CA 92101 US
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Contact KENT SAYLER
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Regulation Number 870.1025

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Classification Product Code DSI
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Date Received 10/20/2009
Decision Date 04/08/2010
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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