FDA 510(k)

Mridium 3870 MRI 輸液泵系統（3870）

K 號：K242752 · 2025-05-28

決定日期2025-05-28

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

MRidium 3870 MRI Infusion Pump System (3870) is the device name listed in this FDA 510(k) record. The listed applicant is Iradimed Corporation. It received FDA 510(k) clearance on 2025-05-28 under 510(k) number K242752. 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 MRidium 3870 MRI Infusion Pump System (3870)?

MRidium 3870 MRI Infusion Pump System (3870) is a medical device that received FDA 510(k) clearance on 2025-05-28. The listed applicant is Iradimed Corporation. The 510(k) number is K242752.

When did MRidium 3870 MRI Infusion Pump System (3870) receive FDA 510(k) clearance?

MRidium 3870 MRI Infusion Pump System (3870) received FDA 510(k) clearance on 2025-05-28, under 510(k) number K242752.

Who is the listed applicant for MRidium 3870 MRI Infusion Pump System (3870)?

The FDA 510(k) record lists Iradimed Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MRidium 3870 MRI Infusion Pump System (3870)?

The FDA product code for MRidium 3870 MRI Infusion Pump System (3870) is FRN.

其他以 Iradimed Corporation 為申請人之記錄

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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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