FDA 510(k)

一次性使用針頭輸液套組

K 號：K221069 · 2022-11-21

申請人Sichuan Prius Biotechnology Co., Ltd.

決定日期2022-11-21

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

Infusion Sets for Single Use with Needles is the device name listed in this FDA 510(k) record. The listed applicant is Sichuan Prius Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2022-11-21 under 510(k) number K221069. 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 Infusion Sets for Single Use with Needles?

Infusion Sets for Single Use with Needles is a medical device that received FDA 510(k) clearance on 2022-11-21. The listed applicant is Sichuan Prius Biotechnology Co., Ltd.. The 510(k) number is K221069.

When did Infusion Sets for Single Use with Needles receive FDA 510(k) clearance?

Infusion Sets for Single Use with Needles received FDA 510(k) clearance on 2022-11-21, under 510(k) number K221069.

Who is the listed applicant for Infusion Sets for Single Use with Needles?

The FDA 510(k) record lists Sichuan Prius Biotechnology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Infusion Sets for Single Use with Needles?

The FDA product code for Infusion Sets for Single Use with Needles is FPA.

其他以 Sichuan Prius Biotechnology 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。

K221078單次使用針頭式靜脈針，安全單次使用針頭式靜脈針 K221075單次使用輸液針頭套件 K221079單次使用无菌皮下注射針筒 K221080單次使用无菌安全針頭 K221073單次使用安全針无菌皮下注射針筒 K221066單次使用无菌皮下針頭

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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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