FDA 510(k)

BD Alaris 靜脈輸注系統配Guardrails Suite MX

K 號：K243855 · 2025-04-25

決定日期2025-04-25

產品代碼FRN

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

BD Alaris Infusion System with Guardrails Suite MX is the device name listed in this FDA 510(k) record. The listed applicant is Carefusion 303, Inc.. It received FDA 510(k) clearance on 2025-04-25 under 510(k) number K243855. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the BD Alaris Infusion System with Guardrails Suite MX?

BD Alaris Infusion System with Guardrails Suite MX is a medical device that received FDA 510(k) clearance on 2025-04-25. The listed applicant is Carefusion 303, Inc.. The 510(k) number is K243855.

When did BD Alaris Infusion System with Guardrails Suite MX receive FDA 510(k) clearance?

BD Alaris Infusion System with Guardrails Suite MX received FDA 510(k) clearance on 2025-04-25, under 510(k) number K243855.

Who is the listed applicant for BD Alaris Infusion System with Guardrails Suite MX?

The FDA 510(k) record lists Carefusion 303, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BD Alaris Infusion System with Guardrails Suite MX?

The FDA product code for BD Alaris Infusion System with Guardrails Suite MX is FRN.

其他以 Carefusion 303, 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：FRN）

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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