FDA 510(k)

IO針安全護罩

K 號：K220890 · 2022-10-31

決定日期2022-10-31

產品代碼FMI

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

IO Needle Safety Sheath is the device name listed in this FDA 510(k) record. The listed applicant is Actuated Medical, Inc.. It received FDA 510(k) clearance on 2022-10-31 under 510(k) number K220890. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the IO Needle Safety Sheath?

IO Needle Safety Sheath is a medical device that received FDA 510(k) clearance on 2022-10-31. The listed applicant is Actuated Medical, Inc.. The 510(k) number is K220890.

When did IO Needle Safety Sheath receive FDA 510(k) clearance?

IO Needle Safety Sheath received FDA 510(k) clearance on 2022-10-31, under 510(k) number K220890.

Who is the listed applicant for IO Needle Safety Sheath?

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

What is the FDA product code for IO Needle Safety Sheath?

The FDA product code for IO Needle Safety Sheath is FMI.

其他以 Actuated Medical, Inc. 為申請人之記錄

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相關器械（代碼：FMI）

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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