FDA 510(k)

ENFit 一次性腸內注射器

K 號：K203410 · 2021-06-28

申請人Shantou Wealy Medical Instrument Co.,Ltd

決定日期2021-06-28

產品代碼PNR

諮詢委員會GU

決定相當於

器材摘要

ENFit Disposable Enteral Syringe is the device name listed in this FDA 510(k) record. The listed applicant is Shantou Wealy Medical Instrument Co.,Ltd. It received FDA 510(k) clearance on 2021-06-28 under 510(k) number K203410. 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 Disposable Enteral Syringe?

ENFit Disposable Enteral Syringe is a medical device that received FDA 510(k) clearance on 2021-06-28. The listed applicant is Shantou Wealy Medical Instrument Co.,Ltd. The 510(k) number is K203410.

When did ENFit Disposable Enteral Syringe receive FDA 510(k) clearance?

ENFit Disposable Enteral Syringe received FDA 510(k) clearance on 2021-06-28, under 510(k) number K203410.

Who is the listed applicant for ENFit Disposable Enteral Syringe?

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

What is the FDA product code for ENFit Disposable Enteral Syringe?

The FDA product code for ENFit Disposable Enteral Syringe is PNR.

其他以 Shantou Wealy Medical Instrument 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。

K222452可棄式自動回彈安全針筒（附可拆卸針頭）K210216一次性自動回彈式胰島素安全針 K203613ENFit 可重用腸內針筒

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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