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FDA 510(k)

高壓管路

K 號:K232388 · 2023-11-21

決定日期2023-11-21
產品代碼DXT
諮詢委員會履歷
決定相當於

器材摘要

High Pressure Tubing is the device name listed in this FDA 510(k) record. The listed applicant is Ningbo Dizegens Medical Science Co.,Ltd. It received FDA 510(k) clearance on 2023-11-21 under 510(k) number K232388. The device is classified under product code DXT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the High Pressure Tubing?

High Pressure Tubing is a medical device that received FDA 510(k) clearance on 2023-11-21. The listed applicant is Ningbo Dizegens Medical Science Co.,Ltd. The 510(k) number is K232388.

When did High Pressure Tubing receive FDA 510(k) clearance?

High Pressure Tubing received FDA 510(k) clearance on 2023-11-21, under 510(k) number K232388.

Who is the listed applicant for High Pressure Tubing?

The FDA 510(k) record lists Ningbo Dizegens Medical Science Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for High Pressure Tubing?

The FDA product code for High Pressure Tubing is DXT.

相關臨床試驗

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其他以 Ningbo Dizegens Medical Science Co.,Ltd 為申請人之記錄

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相關器械(代碼:DXT)

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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