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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
FOIA Releasable 510(k) K121197
Device Name BODYGUARDIAN SYSTEM BODYGUARDIAN CONTROL UNIT BODYGUARDIAN CONNECT
Applicant
PREVENTICE, INC.
2765 COMMERCE DRIVE NW
SUITE 220
ROCHESTER,  MN  55901
Applicant Contact DREW PALIN
Correspondent
PREVENTICE, INC.
2765 COMMERCE DRIVE NW
SUITE 220
ROCHESTER,  MN  55901
Correspondent Contact DREW PALIN
Regulation Number870.1025
Classification Product Code
DSI  
Date Received04/19/2012
Decision Date 08/10/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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