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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 K220786
Device Name STAR Apollo Mapping System
Applicant
Rhythm Al, Ltd
Office G2, Whitney Business and Innovation, Windrush House,
Buford Rd
Witney,  GB OX 29 7DX
Applicant Contact Linda D'Abate
Correspondent
Rhythm-Al
124 Gilbert Stuart Drive
East Greenwich,  RI  02818
Correspondent Contact Linda D'Abate
Regulation Number870.1425
Classification Product Code
DQK  
Date Received03/17/2022
Decision Date 12/01/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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