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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transmitters And Receivers, Electrocardiograph, Telephone
510(k) Number K183704
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
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Mark Job
Regulation Number870.2920
Classification Product Code
DXH  
Date Received12/31/2018
Decision Date 02/16/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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