FDA 510(k)

針筒注射器

K 號：K240774 · 2024-06-18

決定日期2024-06-18

產品代碼FMF

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

Pen Injector is the device name listed in this FDA 510(k) record. The listed applicant is Wuxi Nest Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2024-06-18 under 510(k) number K240774. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Pen Injector?

Pen Injector is a medical device that received FDA 510(k) clearance on 2024-06-18. The listed applicant is Wuxi Nest Biotechnology Co., Ltd.. The 510(k) number is K240774.

When did Pen Injector receive FDA 510(k) clearance?

Pen Injector received FDA 510(k) clearance on 2024-06-18, under 510(k) number K240774.

Who is the listed applicant for Pen Injector?

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

What is the FDA product code for Pen Injector?

The FDA product code for Pen Injector is FMF.

其他以 Wuxi Nest 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。

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相關器械（代碼：FMF）

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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