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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 K153160
Device Name AVIVO Mobile Patient Management (MPM) System
Applicant
MEDTRONIC, INC.
8200 CORAL SEA STREET NE
mounds view,  MN  55112
Applicant Contact cheryl l. swanson
Correspondent
MEDTRONIC, INC.
8200 CORAL SEA STREET NE
mounds view,  MN  55112
Correspondent Contact cheryl l. swanson
Regulation Number870.1025
Classification Product Code
MHX  
Subsequent Product Codes
DSB   DSI  
Date Received11/02/2015
Decision Date 03/30/2016
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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