FDA 510(k)

ENFit腸內輸液泵針筒 PENTA ENFit，ENFit腸內輸液泵針筒 NUTRIFIT

K 號：K161141 · 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 Pump Syringes PENTA ENFit, ENFit Enteral Pump Syringes NUTRIFIT is the device name listed in this FDA 510(k) record. The listed applicant is Pentaferte Italia S.R.L.. It received FDA 510(k) clearance on 2017-03-22 under 510(k) number K161141. 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 Pump Syringes PENTA ENFit, ENFit Enteral Pump Syringes NUTRIFIT?

ENFit Enteral Pump Syringes PENTA ENFit, ENFit Enteral Pump Syringes NUTRIFIT is a medical device that received FDA 510(k) clearance on 2017-03-22. The listed applicant is Pentaferte Italia S.R.L.. The 510(k) number is K161141.

When did ENFit Enteral Pump Syringes PENTA ENFit, ENFit Enteral Pump Syringes NUTRIFIT receive FDA 510(k) clearance?

ENFit Enteral Pump Syringes PENTA ENFit, ENFit Enteral Pump Syringes NUTRIFIT received FDA 510(k) clearance on 2017-03-22, under 510(k) number K161141.

Who is the listed applicant for ENFit Enteral Pump Syringes PENTA ENFit, ENFit Enteral Pump Syringes NUTRIFIT?

The FDA 510(k) record lists Pentaferte Italia S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENFit Enteral Pump Syringes PENTA ENFit, ENFit Enteral Pump Syringes NUTRIFIT?

The FDA product code for ENFit Enteral Pump Syringes PENTA ENFit, ENFit Enteral Pump Syringes NUTRIFIT is PNR.

其他以 Pentaferte Italia S.R.L. 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。

K214080Pentaflush K211661ENFit腸內針筒（NUTRIFIT）

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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