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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name detector and alarm, arrhythmia
510(k) Number K121197
Models 1000, 2000, 2010, 2030
Device Name BODYGUARDIAN SYSTEM BODYGUARDIAN CONTROL UNIT BODYGUARDIAN CONNECT
Original Applicant
PREVENTICE, INC.
2765 commerce drive nw
suite 220
rochester,  MN  55901
Original Contact drew palin
Regulation Number870.1025
Classification Product Code
DSI  
Date Received04/19/2012
Decision Date 08/10/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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