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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Programmable
510(k) Number K253733
Device Name STAR Apollo™ Mapping System
Applicant
Rhythm AI, Ltd.
One London Wall, 6th Floor
London,  GB EC2Y 5EB
Applicant Contact D'Abate Linda
Correspondent
Rhythm AI, Ltd.
One London Wall, 6th Floor
London,  GB EC2Y 5EB
Correspondent Contact D'Abate Linda
Regulation Number870.1425
Classification Product Code
DQK  
Date Received11/24/2025
Decision Date 12/19/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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