Medical Device Manufacturer · US , Chicago , IL

Tempus AI, Inc. - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 2024

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Tempus AI, Inc. Cardiovascular ✕

2 devices

1-2 of 2

Cleared Jul 15, 2025

Tempus ECG-Low EF

Cardiovascular · 180d

Cleared Jun 21, 2024

Cardiovascular · 231d