FDA 510(k)

3880 MRI 患者監護系統

K 號：K180903 · 2019-03-29

決定日期2019-03-29

產品代碼MWI

諮詢委員會履歷

決定相當於

器材摘要

3880 MRI Patient 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 2019-03-29 under 510(k) number K180903. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the 3880 MRI Patient Monitoring System?

3880 MRI Patient Monitoring System is a medical device that received FDA 510(k) clearance on 2019-03-29. The listed applicant is Iradimed Corporation. The 510(k) number is K180903.

When did 3880 MRI Patient Monitoring System receive FDA 510(k) clearance?

3880 MRI Patient Monitoring System received FDA 510(k) clearance on 2019-03-29, under 510(k) number K180903.

Who is the listed applicant for 3880 MRI Patient 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 3880 MRI Patient Monitoring System?

The FDA product code for 3880 MRI Patient Monitoring System is MWI.

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。

K242752Mridium 3870 MRI 輸液泵系統（3870）K1829003880 MRI 患者監護系統 K1722003880 MRI 患者監護系統 K143369Mridium 3860+ MRI 輸注泵/監控系統

相關器械（代碼：MWI）

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。

K260438生命徵象監測器（CLEO2）Infinium Medical, Inc.K253417馬斯美Root監控系統Masimo Corporation K253196Midmark 800 電子生命徵象儀器（1-300-0100，1-300-0200，1-300-0300，1-300-0400）Midmark Corporation K253436c-med0 阿爾法Cosinuss GmbH K250135WAVE醫療平台（2.0.000）Baxter Healthcare Corp/ Excel Medical K241766QMAPP® (Hemo、Hemo Lite、PCM、GO、Hybrid)Fysicon BV

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。