Tempus ECG-PH
K 號：K253699 · 2026-08-21
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器材摘要
Tempus ECG-PH 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 2026-08-21 under 510(k) number K253699. The device is classified under product code SAT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Tempus ECG-PH?
Tempus ECG-PH is a medical device that received FDA 510(k) clearance on 2026-08-21. The listed applicant is Tempus AI, Inc.. The 510(k) number is K253699.
When did Tempus ECG-PH receive FDA 510(k) clearance?
Tempus ECG-PH received FDA 510(k) clearance on 2026-08-21, under 510(k) number K253699.
Who is the listed applicant for Tempus ECG-PH?
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-PH?
The FDA product code for Tempus ECG-PH is SAT.
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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：SAT）
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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