FDA 510(k)

Tempus ECG-MR

K号: K254297 · 2026-09-25

决定日期2026-09-25

产品代码SBQ

咨询委员会CV

决定Substantially Equivalent

器械摘要

Tempus ECG-MR 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 2026-09-25 under 510(k) number K254297. The device is classified under product code SBQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Tempus ECG-MR?

Tempus ECG-MR is a medical device that received FDA 510(k) clearance on 2026-09-25. The listed applicant is Tempus AI, Inc.. The 510(k) number is K254297.

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

Tempus ECG-MR received FDA 510(k) clearance on 2026-09-25, under 510(k) number K254297.

Who is the listed applicant for Tempus ECG-MR?

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-MR?

The FDA product code for Tempus ECG-MR is SBQ.

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。

K253699Tempus ECG-PH K241868xR IVD K250119Tempus ECG-Low EF K233549Tempus ECG-AF

官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。