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FDA 510(k)

InfuLife

K 號:K240624 · 2024-11-05

決定日期2024-11-05
產品代碼MEB
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

InfuLife is the device name listed in this FDA 510(k) record. The listed applicant is First Medical Source, LLC. It received FDA 510(k) clearance on 2024-11-05 under 510(k) number K240624. The device is classified under product code MEB. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the InfuLife?

InfuLife is a medical device that received FDA 510(k) clearance on 2024-11-05. The listed applicant is First Medical Source, LLC. The 510(k) number is K240624.

When did InfuLife receive FDA 510(k) clearance?

InfuLife received FDA 510(k) clearance on 2024-11-05, under 510(k) number K240624.

Who is the listed applicant for InfuLife?

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

What is the FDA product code for InfuLife?

The FDA product code for InfuLife is MEB.

相關臨床試驗

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相關器械(代碼:MEB)

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。

官方來源

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