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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 K240509
Device Name STAR Apollo™ Mapping System
Applicant
Rhythm AI, Ltd.
One London Wall, 6th Floor
London,  GB EC2Y 5EB
Applicant Contact Linda D'Abate
Correspondent
Rhythm Ai, Inc.
4225 Executive Square, Suite 600
La Jolla,  CA  92037
Correspondent Contact Linda D'Abate
Regulation Number870.1425
Classification Product Code
DQK  
Date Received02/22/2024
Decision Date 07/26/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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