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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Outpatient Cardiac Telemetry
510(k) Number K241179
Device Name Rhythm Express Remote Cardiac Monitoring System (RX-1 mini)
Applicant
Vivaquant, Inc.
1265 Grey Fox Rd.
Suite 400
Arden Hills,  MN  55112
Applicant Contact Brian Brockway
Correspondent
DuVal & Associates, P.A.
825 Nicollet Mall, Suite 1820
Medical Arts Bldg.
Minneapolois,  MN  55402
Correspondent Contact Kathy Herzog
Regulation Number870.1025
Classification Product Code
QYX  
Subsequent Product Codes
DSI   MLO  
Date Received04/29/2024
Decision Date 07/11/2025
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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