FDA 510(k)

Tempus ECG-Low EF

K号: K250119 · 2025-07-15

决定日期2025-07-15

产品代码QYE

咨询委员会CV

决定Substantially Equivalent

器械摘要

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

常见问题

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. The listed applicant is Tempus AI, Inc.. The 510(k) number is K250119.

When did Tempus ECG-Low EF receive FDA 510(k) clearance?

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

Who is the listed applicant for Tempus ECG-Low EF?

The FDA 510(k) record lists Tempus AI, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

列明Tempus AI, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K254297Tempus ECG-MR K253699Tempus ECG-PH K241868xR IVD K233549Tempus ECG-AF

官方来源

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