FDA 510(k)

Mridium 3860+ MRI 輸注泵/監控系統

K 號：K143369 · 2016-12-15

決定日期2016-12-15

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 3860+ MRI infusion Pump/ Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Iradimed Corporation. It received FDA 510(k) clearance on 2016-12-15 under 510(k) number K143369. 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 3860+ MRI infusion Pump/ Monitoring System?

MRidium 3860+ MRI infusion Pump/ Monitoring System is a medical device that received FDA 510(k) clearance on 2016-12-15. The listed applicant is Iradimed Corporation. The 510(k) number is K143369.

When did MRidium 3860+ MRI infusion Pump/ Monitoring System receive FDA 510(k) clearance?

MRidium 3860+ MRI infusion Pump/ Monitoring System received FDA 510(k) clearance on 2016-12-15, under 510(k) number K143369.

Who is the listed applicant for MRidium 3860+ MRI infusion Pump/ Monitoring System?

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 3860+ MRI infusion Pump/ Monitoring System?

The FDA product code for MRidium 3860+ MRI infusion Pump/ Monitoring System is FRN.

其他以 Iradimed Corporation 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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