FDA 510(k)

Radical-7 脈搏式血氧濃度計及附件，Rad-97 及附件

K 號：K212161 · 2023-03-06

決定日期2023-03-06

產品代碼MWI

諮詢委員會履歷

決定相當於

器材摘要

Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and Accessories is the device name listed in this FDA 510(k) record. The listed applicant is Masimo Corporation. It received FDA 510(k) clearance on 2023-03-06 under 510(k) number K212161. 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 Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and Accessories?

Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and Accessories is a medical device that received FDA 510(k) clearance on 2023-03-06. The listed applicant is Masimo Corporation. The 510(k) number is K212161.

When did Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and Accessories receive FDA 510(k) clearance?

Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and Accessories received FDA 510(k) clearance on 2023-03-06, under 510(k) number K212161.

Who is the listed applicant for Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and Accessories?

FDA 510(k) 記錄中將 Masimo Corporation 列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and Accessories?

The FDA product code for Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and Accessories is MWI.

其他以 Masimo 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。

K253417馬斯美Root監控系統 K260880SedLine 鎮靜監護儀 K254209Radius VSM 及其附件 K243324馬斯米O3地區性血氧儀 K250757Radius VSM 及其附件 K243305馬西莫W1

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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

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