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FDA 510(k)

ENFit腸內針筒

K 號:K161979 · 2017-03-22

決定日期2017-03-22
產品代碼PNR
諮詢委員會GU
決定相當於

器材摘要

ENFit enteral syringe is the device name listed in this FDA 510(k) record. The listed applicant is Jiangyin Caina Technology Co., Ltd.. It received FDA 510(k) clearance on 2017-03-22 under 510(k) number K161979. 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 ENFit enteral syringe?

ENFit enteral syringe is a medical device that received FDA 510(k) clearance on 2017-03-22. The listed applicant is Jiangyin Caina Technology Co., Ltd.. The 510(k) number is K161979.

When did ENFit enteral syringe receive FDA 510(k) clearance?

ENFit enteral syringe received FDA 510(k) clearance on 2017-03-22, under 510(k) number K161979.

Who is the listed applicant for ENFit enteral syringe?

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

What is the FDA product code for ENFit enteral syringe?

The FDA product code for ENFit enteral syringe is PNR.

相關臨床試驗

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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。

官方來源

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