FDA 510(k)

動脈針管

K 號：K201726 · 2021-07-07

決定日期2021-07-07

產品代碼DQY

諮詢委員會履歷

決定相當於

器材摘要

Arterial Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Haolang Medical USA Corporation. It received FDA 510(k) clearance on 2021-07-07 under 510(k) number K201726. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Arterial Catheter?

Arterial Catheter is a medical device that received FDA 510(k) clearance on 2021-07-07. The listed applicant is Haolang Medical USA Corporation. The 510(k) number is K201726.

When did Arterial Catheter receive FDA 510(k) clearance?

Arterial Catheter received FDA 510(k) clearance on 2021-07-07, under 510(k) number K201726.

Who is the listed applicant for Arterial Catheter?

The FDA 510(k) record lists Haolang Medical USA Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Arterial Catheter?

The FDA product code for Arterial Catheter is DQY.

其他以 Haolang Medical USA Corporation 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：DQY）

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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