FDA 510(k)

Q2 靜脈輸血套件

K 號：K213846 · 2022-06-05

決定日期2022-06-05

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

Q2 Blood Administration Sets is the device name listed in this FDA 510(k) record. The listed applicant is Quest Medical, Inc.. It received FDA 510(k) clearance on 2022-06-05 under 510(k) number K213846. 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 Q2 Blood Administration Sets?

Q2 Blood Administration Sets is a medical device that received FDA 510(k) clearance on 2022-06-05. The listed applicant is Quest Medical, Inc.. The 510(k) number is K213846.

When did Q2 Blood Administration Sets receive FDA 510(k) clearance?

Q2 Blood Administration Sets received FDA 510(k) clearance on 2022-06-05, under 510(k) number K213846.

Who is the listed applicant for Q2 Blood Administration Sets?

The FDA 510(k) record lists Quest Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Q2 Blood Administration Sets?

The FDA product code for Q2 Blood Administration Sets is FPA.

其他以 Quest Medical, Inc. 為申請人之記錄

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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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官方來源

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