FDA 510(k)

霍爾特心電圖與血壓監測系統（HolterABP）

K 號：K251591 · 2026-02-09

決定日期2026-02-09

產品代碼DQK

諮詢委員會履歷

決定相當於

器材摘要

Holter ECG and ABP system (HolterABP) is the device name listed in this FDA 510(k) record. The listed applicant is Edan Instruments, Inc.. It received FDA 510(k) clearance on 2026-02-09 under 510(k) number K251591. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Holter ECG and ABP system (HolterABP)?

Holter ECG and ABP system (HolterABP) is a medical device that received FDA 510(k) clearance on 2026-02-09. The listed applicant is Edan Instruments, Inc.. The 510(k) number is K251591.

When did Holter ECG and ABP system (HolterABP) receive FDA 510(k) clearance?

Holter ECG and ABP system (HolterABP) received FDA 510(k) clearance on 2026-02-09, under 510(k) number K251591.

Who is the listed applicant for Holter ECG and ABP system (HolterABP)?

FDA 510(k) 記錄將 Edan Instruments, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Holter ECG and ABP system (HolterABP)?

The FDA product code for Holter ECG and ABP system (HolterABP) is DQK.

其他以 Edan Instruments, Inc. 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。

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相關器械（代碼：DQK）

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。

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官方來源

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