FDA 510(k)

Carefusion NeutraClear 非針連接器

K 號：K171132 · 2017-07-31

決定日期2017-07-31

產品代碼FPA

諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。

決定相當於

器材摘要

Carefusion NeutraClear Needle-free connector is the device name listed in this FDA 510(k) record. The listed applicant is Cair Lgl. It received FDA 510(k) clearance on 2017-07-31 under 510(k) number K171132. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Carefusion NeutraClear Needle-free connector?

Carefusion NeutraClear Needle-free connector is a medical device that received FDA 510(k) clearance on 2017-07-31. The listed applicant is Cair Lgl. The 510(k) number is K171132.

When did Carefusion NeutraClear Needle-free connector receive FDA 510(k) clearance?

Carefusion NeutraClear Needle-free connector received FDA 510(k) clearance on 2017-07-31, under 510(k) number K171132.

Who is the listed applicant for Carefusion NeutraClear Needle-free connector?

The FDA 510(k) record lists Cair Lgl as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Carefusion NeutraClear Needle-free connector?

The FDA product code for Carefusion NeutraClear Needle-free connector is FPA.

其他以 Cair Lgl 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。

K231299Nutricair腸內ENFit轉接器：ENFit公頭－階梯/耶誕樹型接頭 K231300Nutricair 內腸注射器配ENFit K213258鼻胃管 - ENFit 接口 - 聚氯乙烯 K210598兒童鼻胃管輸食管 - 单一ENFit端口 K171117Carefusion NeutraClear 非針連接器 (EL-NC1000)K171118Carefusion NeutraClear 多連接器擴展組合，配無針接頭(們)

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相關器械（代碼：FPA）

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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