FDA 510(k) Application Details - K090696

Device Classification Name Detector And Alarm, Arrhythmia

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510(K) Number K090696
Device Name Detector And Alarm, Arrhythmia
Applicant CORVENTIS, INC.
2226 N. FIRST STREET
SAN JOSE, CA 95131 US
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Contact MADHURI BHAT
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Regulation Number 870.1025

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Classification Product Code DSI
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Date Received 03/16/2009
Decision Date 06/19/2009
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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