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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 K233584
Device Name RhythmStar System
Applicant
RhythMedix, LLC
5000 Atrium Way
Suite #1
Mt. Laurel,  NJ  08054
Applicant Contact Stan Biletsky
Correspondent
RhythMedix, LLC
5000 Atrium Way
Suite #1
Mt. Laurel,  NJ  08054
Correspondent Contact Rita King
Regulation Number870.1025
Classification Product Code
QYX  
Date Received11/07/2023
Decision Date 07/08/2024
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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