FDA 510(k)

一次性內腸管輸食針筒，配Enfit連接器

K 號：K193657 · 2020-09-12

申請人Shinva Ande Healthcare Apparatus Co., Ltd.

決定日期2020-09-12

產品代碼PNR

諮詢委員會GU

決定相當於

器材摘要

Disposable Enteral Feeding Syringe with Enfit Connector is the device name listed in this FDA 510(k) record. The listed applicant is Shinva Ande Healthcare Apparatus Co., Ltd.. It received FDA 510(k) clearance on 2020-09-12 under 510(k) number K193657. 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 Disposable Enteral Feeding Syringe with Enfit Connector?

Disposable Enteral Feeding Syringe with Enfit Connector is a medical device that received FDA 510(k) clearance on 2020-09-12. The listed applicant is Shinva Ande Healthcare Apparatus Co., Ltd.. The 510(k) number is K193657.

When did Disposable Enteral Feeding Syringe with Enfit Connector receive FDA 510(k) clearance?

Disposable Enteral Feeding Syringe with Enfit Connector received FDA 510(k) clearance on 2020-09-12, under 510(k) number K193657.

Who is the listed applicant for Disposable Enteral Feeding Syringe with Enfit Connector?

The FDA 510(k) record lists Shinva Ande Healthcare Apparatus Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Enteral Feeding Syringe with Enfit Connector?

The FDA product code for Disposable Enteral Feeding Syringe with Enfit Connector is PNR.

其他以 Shinva Ande Healthcare Apparatus 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。

K201460閉環系統轉移設備 K220057一次性无菌針筒，針筒永久固定針頭；固定劑量免疫注射自動停用針筒 K211484一次性无菌針筒；帶針一次性无菌針筒；一次性无菌針筒；一次性安全針 K202060一次性靜脈針管 K162601單次使用輸液針頭

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。

K252483腸內針筒（20ml, 60ml）Chirana T.Injecta,A.S.K253268Profoject 鼻胃/口內喂養注射器；Profoject 可重用鼻胃/口內喂養注射器（型號A，型號B）；Profoject ENFit 轉接器；Profoject 鼻胃喂養注射器蓋CMT Health PTE., Ltd.K251585Profoject™ 給藥注射器CMT Health PTE., Ltd.K243652Monoject™ 飲食針筒配ENFit連接器（401SE）；Monoject™ 飲食針筒配ENFit連接器（403SE）；Monoject™ 飲食針筒配ENFit連接器（406SE）；Monoject™ 飲食針筒配ENFit連接器（412SE）；Monoject™ 飲食針筒配ENFit連接器（435SE）；Monoject™ 飲食針筒配ENFit連接器（460SE）Cardinalhealth K231300Nutricair 內腸注射器配ENFitCair Lgl K222772口服/腸內針筒配ENFit連接器Anhui Tiankang Medical Technology Co., Ltd.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。