Tempus ECG-Low EF
K 號：K250119 · 2025-07-15
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器材摘要
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.
常見問題
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.
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其他以 Tempus AI, Inc. 為申請人之記錄
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相關器械（代碼：QYE）
相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。
官方來源
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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