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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name monitor, physiological, patient(with arrhythmia detection or alarms)
510(k) Number K113187
Device Name AVIVO MOBILE PATIENT MANAGEMENT
Original Applicant
CORVENTIS, INC.
1410 energy park drive
suite 1
saint paul,  MN  55108
Original Contact kathleen lundberg
Regulation Number870.1025
Classification Product Code
MHX  
Subsequent Product Codes
DSB   DSI  
Date Received10/31/2011
Decision Date 01/04/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Abbreviated
Reviewed by Third Party No
Expedited Review No
Combination Product No
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