FDA 510(k)

Carefusion NeutraClear 非針連接器 (EL-NC1000)

K 號：K171117 · 2017-09-01

決定日期2017-09-01

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 (EL-NC1000) is the device name listed in this FDA 510(k) record. The listed applicant is Cair Lgl. It received FDA 510(k) clearance on 2017-09-01 under 510(k) number K171117. 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 (EL-NC1000)?

Carefusion NeutraClear Needle-free connector (EL-NC1000) is a medical device that received FDA 510(k) clearance on 2017-09-01. The listed applicant is Cair Lgl. The 510(k) number is K171117.

When did Carefusion NeutraClear Needle-free connector (EL-NC1000) receive FDA 510(k) clearance?

Carefusion NeutraClear Needle-free connector (EL-NC1000) received FDA 510(k) clearance on 2017-09-01, under 510(k) number K171117.

Who is the listed applicant for Carefusion NeutraClear Needle-free connector (EL-NC1000)?

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 (EL-NC1000)?

The FDA product code for Carefusion NeutraClear Needle-free connector (EL-NC1000) 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。

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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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