FDA 510(k)

ECG-AI 心臟膽固醇蛋白積聚症 (CA) 12 領導電圖演算法 (1040)

K 號：K253801 · 2026-04-07

決定日期2026-04-07

產品代碼SHP

諮詢委員會履歷

決定相當於

器材摘要

ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040) is the device name listed in this FDA 510(k) record. The listed applicant is Anumana, Inc.. It received FDA 510(k) clearance on 2026-04-07 under 510(k) number K253801. The device is classified under product code SHP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040)?

ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040) is a medical device that received FDA 510(k) clearance on 2026-04-07. The listed applicant is Anumana, Inc.. The 510(k) number is K253801.

When did ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040) receive FDA 510(k) clearance?

ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040) received FDA 510(k) clearance on 2026-04-07, under 510(k) number K253801.

Who is the listed applicant for ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040)?

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

What is the FDA product code for ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040)?

The FDA product code for ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040) is SHP.

其他以 Anumana, Inc. 為申請人之記錄

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官方來源

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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。

器材摘要

常見問題

相關臨床試驗

其他以 Anumana, Inc. 為申請人之記錄

官方來源