FDA 510(k)

U&U腸內注射器

K 號：K160855 · 2016-11-22

決定日期2016-11-22

產品代碼PNR

諮詢委員會GU

決定相當於

器材摘要

U&U Enteral Syringe is the device name listed in this FDA 510(k) record. The listed applicant is U&U Medical Technology Co, Ltd.. It received FDA 510(k) clearance on 2016-11-22 under 510(k) number K160855. The device is classified under product code PNR. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the U&U Enteral Syringe?

U&U Enteral Syringe is a medical device that received FDA 510(k) clearance on 2016-11-22. The listed applicant is U&U Medical Technology Co, Ltd.. The 510(k) number is K160855.

When did U&U Enteral Syringe receive FDA 510(k) clearance?

U&U Enteral Syringe received FDA 510(k) clearance on 2016-11-22, under 510(k) number K160855.

Who is the listed applicant for U&U Enteral Syringe?

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

What is the FDA product code for U&U Enteral Syringe?

The FDA product code for U&U Enteral Syringe is PNR.

其他以 U&U Medical Technology Co, Ltd. 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。

K181508U&U 體液採集套件 K171823U&U 指示膠帶及條 K152808U&U 胰島素針筒（含/不含安全回抽裝置）

相關器械（代碼：PNR）

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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