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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 K233755
Device Name HeartKey® Rhythm
Applicant
B-Secur Limited
11th Floor, City Quays 3
92 Donegall Quay
Belfast,  GB BT1 3FE
Applicant Contact Cameron Moore
Correspondent
B-Secur Limited
11th Floor, City Quays 3
92 Donegall Quay
Belfast,  GB BT1 3FE
Correspondent Contact Cameron Moore
Regulation Number870.1425
Classification Product Code
DQK  
Subsequent Product Code
DPS  
Date Received11/22/2023
Decision Date 08/16/2024
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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