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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
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