FDA 510(k)

Accurate Mini 非侵入性血壓監測器 (AMB-001)

K 號：K242352 · 2025-02-05

決定日期2025-02-05

產品代碼DXN

諮詢委員會履歷

決定相當於

器材摘要

Accurate Mini Non-invasive blood pressure monitor (AMB-001) is the device name listed in this FDA 510(k) record. The listed applicant is Accurate Meditech, Inc.. It received FDA 510(k) clearance on 2025-02-05 under 510(k) number K242352. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Accurate Mini Non-invasive blood pressure monitor (AMB-001)?

Accurate Mini Non-invasive blood pressure monitor (AMB-001) is a medical device that received FDA 510(k) clearance on 2025-02-05. The listed applicant is Accurate Meditech, Inc.. The 510(k) number is K242352.

When did Accurate Mini Non-invasive blood pressure monitor (AMB-001) receive FDA 510(k) clearance?

Accurate Mini Non-invasive blood pressure monitor (AMB-001) received FDA 510(k) clearance on 2025-02-05, under 510(k) number K242352.

Who is the listed applicant for Accurate Mini Non-invasive blood pressure monitor (AMB-001)?

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

What is the FDA product code for Accurate Mini Non-invasive blood pressure monitor (AMB-001)?

The FDA product code for Accurate Mini Non-invasive blood pressure monitor (AMB-001) is DXN.

其他以 Accurate Meditech, 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。

K222658Accurate 24 非侵入性血壓監測器

相關器械（代碼：DXN）

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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