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FDA 510(k)

Meditech ABPM-06 (BP6)

K 號:K201332 · 2021-02-10

決定日期2021-02-10
產品代碼DXN
諮詢委員會履歷
決定相當於

器材摘要

Meditech ABPM-06 (BP6) is the device name listed in this FDA 510(k) record. The listed applicant is Meditech , Ltd.. It received FDA 510(k) clearance on 2021-02-10 under 510(k) number K201332. 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 Meditech ABPM-06 (BP6)?

Meditech ABPM-06 (BP6) is a medical device that received FDA 510(k) clearance on 2021-02-10. The listed applicant is Meditech , Ltd.. The 510(k) number is K201332.

When did Meditech ABPM-06 (BP6) receive FDA 510(k) clearance?

Meditech ABPM-06 (BP6) received FDA 510(k) clearance on 2021-02-10, under 510(k) number K201332.

Who is the listed applicant for Meditech ABPM-06 (BP6)?

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

What is the FDA product code for Meditech ABPM-06 (BP6)?

The FDA product code for Meditech ABPM-06 (BP6) is DXN.

相關臨床試驗

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。

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。

官方來源

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