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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 K192732
Device Name BodyGuardian Remote Monitoring System
Applicant
Preventice Technologies, Inc.
3052 Hwy52 N, Building 003-2
Rochester,  MN  55901
Applicant Contact Charles Rector
Correspondent
Preventice Technologies, Inc.
3052 Hwy52 N, Building 003-2
Rochester,  MN  55901
Correspondent Contact Charles Rector
Regulation Number870.1025
Classification Product Code
DSI  
Date Received09/27/2019
Decision Date 03/26/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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