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FDA 510(k)

Tempus ECG-Low EF

K-Number: K250119 · 2025-07-15

ApplicantTempus AI, Inc.
Decision Date2025-07-15
Product CodeQYE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Tempus ECG-Low EF is a medical device manufactured by Tempus AI, Inc.. It received FDA 510(k) clearance on 2025-07-15 under approval number K250119. The device is classified under product code QYE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Tempus ECG-Low EF?

Tempus ECG-Low EF is a medical device that received FDA 510(k) clearance on 2025-07-15. It is manufactured by Tempus AI, Inc.. The 510(k) number is K250119.

When was Tempus ECG-Low EF approved by the FDA?

Tempus ECG-Low EF received FDA 510(k) clearance on 2025-07-15, under approval number K250119.

What company makes Tempus ECG-Low EF?

Tempus ECG-Low EF is manufactured by Tempus AI, Inc..

What is the FDA product code for Tempus ECG-Low EF?

The FDA product code for Tempus ECG-Low EF is QYE.

Other Devices by Tempus AI, Inc.

K233549Tempus ECG-AF K241868xR IVD

Related Devices (Code: QYE)

K232699Low Ejection Fraction AI-ECG AlgorithmAnumana, Inc. K233409Eko Low Ejection Fraction Tool (ELEFT)Eko Health, Inc. K250649Bunkerhill ECG-EFBunkerHill Health K250652ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)Anumana, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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