FDA 510(k)

口內/腸內針筒（10 mL 至 60 mL）及低劑量針頭口內/腸內針筒（1 mL 至 5 mL）

K 號：K181426 · 2018-10-11

申請人Jiangsu Micsafe Medical Technology Co., Ltd.

決定日期2018-10-11

產品代碼PNR

諮詢委員會GU

決定相當於

器材摘要

Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe (1 mL to 5 mL) is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Micsafe Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2018-10-11 under 510(k) number K181426. 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 Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe (1 mL to 5 mL)?

Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe (1 mL to 5 mL) is a medical device that received FDA 510(k) clearance on 2018-10-11. The listed applicant is Jiangsu Micsafe Medical Technology Co., Ltd.. The 510(k) number is K181426.

When did Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe (1 mL to 5 mL) receive FDA 510(k) clearance?

Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe (1 mL to 5 mL) received FDA 510(k) clearance on 2018-10-11, under 510(k) number K181426.

Who is the listed applicant for Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe (1 mL to 5 mL)?

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

What is the FDA product code for Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe (1 mL to 5 mL)?

The FDA product code for Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe (1 mL to 5 mL) is PNR.

其他以 Jiangsu Micsafe 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。

K212019單次使用血液採集針及帶針座單次使用血液採集針，單次使用安全血液採集針及帶針座單次使用安全血液採集針，單次使用血液採集套組及帶針座單次使用安全血液採集套組，單次使用安全血液採集套組及帶針座單次使用血液採集套組 K202570胰島素針筒，安全可回收式胰島素針筒 K202205外科口罩 K183665安全針，无菌針筒，帶安全針的无菌針筒，帶針的无菌針筒，一次性使用皮下針

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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