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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 K250793
Device Name RhythmStar System (SL)
Applicant
RhythMedix, LLC
5000 Atrium Way
Suite #1
Mt. Laurel,  NJ  08054
Applicant Contact Stan Biletsky
Correspondent
MethodSense, Inc.
1 Copley Pkwy.
Suite 130
Morrisville,  NC  27560
Correspondent Contact Rita King
Regulation Number870.1025
Classification Product Code
QYX  
Date Received03/14/2025
Decision Date 04/21/2026
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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