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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name electrocardiograph, ambulatory, with analysis algorithm
510(k) Number K200833
Device Name RX-1 Rhythm Express Remote Cardiac Monitoring System
Applicant
VivaQuant Inc.
4339 Nancy Place, Suite 100
st. paul,  MN  55126
Applicant Contact brian brockway
Correspondent
Borderless Compliance, LLC
7118 Teakwood Cir
maple grove,  MN  55369
Correspondent Contact brodie pedersen
Regulation Number870.2800
Classification Product Code
MLO  
Subsequent Product Code
DSI  
Date Received03/30/2020
Decision Date 09/02/2020
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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