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FDA 510(k) Application Details - K083287
Device Classification Name
Detector And Alarm, Arrhythmia
More FDA Info for this Device
510(K) Number
K083287
Device Name
Detector And Alarm, Arrhythmia
Applicant
CORVENTIS, INC.
2226 N. FIRST STREET
SAN JOSE, CA 95131 US
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Contact
DAWN CHANG
Other 510(k) Applications for this Contact
Regulation Number
870.1025
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Classification Product Code
DSI
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More FDA Info for this Product Code
Date Received
11/07/2008
Decision Date
02/03/2009
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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