FDA 510(k)

Bunkerhill 心電圖-射血量

K 號：K250649 · 2025-09-19

決定日期2025-09-19

產品代碼QYE

諮詢委員會履歷

決定相當於

器材摘要

Bunkerhill ECG-EF is the device name listed in this FDA 510(k) record. The listed applicant is BunkerHill Health. It received FDA 510(k) clearance on 2025-09-19 under 510(k) number K250649. 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 Bunkerhill ECG-EF?

Bunkerhill ECG-EF is a medical device that received FDA 510(k) clearance on 2025-09-19. The listed applicant is BunkerHill Health. The 510(k) number is K250649.

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

Bunkerhill ECG-EF received FDA 510(k) clearance on 2025-09-19, under 510(k) number K250649.

Who is the listed applicant for Bunkerhill ECG-EF?

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

What is the FDA product code for Bunkerhill ECG-EF?

The FDA product code for Bunkerhill ECG-EF is QYE.

其他以 BunkerHill Health 為申請人之記錄

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。

K260167Bunkerhill對比AVC K260166Bunkerhill對比CAC K250662Bunkerhill MAC K243779Bunkerhill 腹部主动脉量化 (AAQ)K242295BunkerHill BMD K243229Bunkerhill AVC

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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。

K250652ECG-AI 低射血量分數（LEF）12導電路演算法（1010）Anumana, Inc.K250119Tempus 心電圖-低射血量Tempus AI, Inc.K233409Eko 低射血量工具 (ELEFT)Eko Health, Inc.K232699低射血量AI電心圖算法Anumana, Inc.

官方來源

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