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FDA 510(k)

醫用連接式可重用血壓袖帶

K 號:K173869 · 2018-08-02

決定日期2018-08-02
產品代碼DXQ
諮詢委員會履歷
決定相當於

器材摘要

Med-link Reusable Blood Pressure Cuff is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Med-Link Electronics Tech Co., Ltd.. It received FDA 510(k) clearance on 2018-08-02 under 510(k) number K173869. The device is classified under product code DXQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Med-link Reusable Blood Pressure Cuff?

Med-link Reusable Blood Pressure Cuff is a medical device that received FDA 510(k) clearance on 2018-08-02. The listed applicant is Shenzhen Med-Link Electronics Tech Co., Ltd.. The 510(k) number is K173869.

When did Med-link Reusable Blood Pressure Cuff receive FDA 510(k) clearance?

Med-link Reusable Blood Pressure Cuff received FDA 510(k) clearance on 2018-08-02, under 510(k) number K173869.

Who is the listed applicant for Med-link Reusable Blood Pressure Cuff?

The FDA 510(k) record lists Shenzhen Med-Link Electronics Tech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Med-link Reusable Blood Pressure Cuff?

The FDA product code for Med-link Reusable Blood Pressure Cuff is DXQ.

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其他以 Shenzhen Med-Link Electronics Tech Co., Ltd. 為申請人之記錄

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相關器械(代碼:DXQ)

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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