FDA 510(k)

內腸輸食針筒配ENfit接頭（型號：10 ml；60 ml控制環）

K 號：K200557 · 2020-09-28

申請人Jiangsu Shenli Medical Production Co., Ltd.

決定日期2020-09-28

產品代碼PNR

諮詢委員會GU

決定相當於

器材摘要

Enteral Feeding Syringes with ENfit connector (Model: 10 ml; 60 ml control ring) is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Shenli Medical Production Co., Ltd.. It received FDA 510(k) clearance on 2020-09-28 under 510(k) number K200557. 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 Enteral Feeding Syringes with ENfit connector (Model: 10 ml; 60 ml control ring)?

Enteral Feeding Syringes with ENfit connector (Model: 10 ml; 60 ml control ring) is a medical device that received FDA 510(k) clearance on 2020-09-28. The listed applicant is Jiangsu Shenli Medical Production Co., Ltd.. The 510(k) number is K200557.

When did Enteral Feeding Syringes with ENfit connector (Model: 10 ml; 60 ml control ring) receive FDA 510(k) clearance?

Enteral Feeding Syringes with ENfit connector (Model: 10 ml; 60 ml control ring) received FDA 510(k) clearance on 2020-09-28, under 510(k) number K200557.

Who is the listed applicant for Enteral Feeding Syringes with ENfit connector (Model: 10 ml; 60 ml control ring)?

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

What is the FDA product code for Enteral Feeding Syringes with ENfit connector (Model: 10 ml; 60 ml control ring)?

The FDA product code for Enteral Feeding Syringes with ENfit connector (Model: 10 ml; 60 ml control ring) is PNR.

其他以 Jiangsu Shenli Medical Production Co., Ltd. 為申請人之記錄

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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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