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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 K151188
Device Name BodyGuardian Remote Monitoring System
Applicant
PREVENTICE
2765 COMMERCE DRIVE NW, #220
ROCHESTER,  MN  55901
Applicant Contact CHARLIE RECTOR
Correspondent
PREVENTICE
2765 COMMERCE DRIVE NW, #220
ROCHESTER,  MN  55901
Correspondent Contact CHARLIE RECTOR
Regulation Number870.1025
Classification Product Code
DSI  
Date Received05/04/2015
Decision Date 09/17/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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