510(k) K233549

Device

Tempus ECG-AF

Applicant

Tempus AI, Inc.

510(k) number

K233549

Product code

SBQ

Decision

Substantially Equivalent (SESE)

Decision date

2024-06-21

Date received

2023-11-03

Regulation

870.2380

Classification name

Atrial Fibrillation Risk Prediction Machine Learning-Based Notification Software

Medical specialty

Cardiovascular

Review panel

Cardiovascular

Device class

2

Clearance type

Traditional

Statement or summary

Summary

Third party reviewed

No