Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
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
-
-