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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  
Subsequent Product Code
DHX  
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
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