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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Atrial Fibrillation Risk Prediction Machine Learning-Based Notification Software
510(k) Number K233549
Device Name Tempus ECG-AF
Applicant
Tempus Ai, Inc.
600 W Chicago Ave. Suite #510
Chicago,  IL  60654
Applicant Contact Alain Silk
Correspondent
Tempus Ai, Inc.
600 W Chicago Ave. Suite #510
Chicago,  IL  60654
Correspondent Contact Alain Silk
Classification Product Code
SBQ  
Date Received11/03/2023
Decision Date 06/21/2024
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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