FDA 510(k)

單次使用針頭式靜脈針，安全單次使用針頭式靜脈針

K 號：K221078 · 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

Intravenous Needles for Single Use,Safety Intravenous Needles for Single Use 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 K221078. 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 Intravenous Needles for Single Use,Safety Intravenous Needles for Single Use?

Intravenous Needles for Single Use,Safety Intravenous Needles for Single Use 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 K221078.

When did Intravenous Needles for Single Use,Safety Intravenous Needles for Single Use receive FDA 510(k) clearance?

Intravenous Needles for Single Use,Safety Intravenous Needles for Single Use received FDA 510(k) clearance on 2022-11-21, under 510(k) number K221078.

Who is the listed applicant for Intravenous Needles for Single Use,Safety Intravenous Needles for Single Use?

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 Intravenous Needles for Single Use,Safety Intravenous Needles for Single Use?

The FDA product code for Intravenous Needles for Single Use,Safety Intravenous Needles for Single Use 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。

K221075單次使用輸液針頭套件 K221069一次性使用針頭輸液套組 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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