FDA 510(k)

混合與輸送系統

K 號：K192674 · 2020-02-18

決定日期2020-02-18

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

Mixing and Delivery System is the device name listed in this FDA 510(k) record. The listed applicant is Bone Solutions, Inc.. It received FDA 510(k) clearance on 2020-02-18 under 510(k) number K192674. 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 Mixing and Delivery System?

Mixing and Delivery System is a medical device that received FDA 510(k) clearance on 2020-02-18. The listed applicant is Bone Solutions, Inc.. The 510(k) number is K192674.

When did Mixing and Delivery System receive FDA 510(k) clearance?

Mixing and Delivery System received FDA 510(k) clearance on 2020-02-18, under 510(k) number K192674.

Who is the listed applicant for Mixing and Delivery System?

FDA 510(k) 記錄將 Bone Solutions, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Mixing and Delivery System?

The FDA product code for Mixing and Delivery System is FMF.

其他以 Bone Solutions, Inc. 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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