FDA 510(k)

馬斯米O3地區性血氧儀

K 號：K243324 · 2025-07-17

決定日期2025-07-17

產品代碼MUD

諮詢委員會履歷

決定相當於

器材摘要

Masimo O3 Regional Oximeter is the device name listed in this FDA 510(k) record. The listed applicant is Masimo Corporation. It received FDA 510(k) clearance on 2025-07-17 under 510(k) number K243324. The device is classified under product code MUD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Masimo O3 Regional Oximeter?

Masimo O3 Regional Oximeter is a medical device that received FDA 510(k) clearance on 2025-07-17. The listed applicant is Masimo Corporation. The 510(k) number is K243324.

When did Masimo O3 Regional Oximeter receive FDA 510(k) clearance?

Masimo O3 Regional Oximeter received FDA 510(k) clearance on 2025-07-17, under 510(k) number K243324.

Who is the listed applicant for Masimo O3 Regional Oximeter?

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 Masimo O3 Regional Oximeter?

The FDA product code for Masimo O3 Regional Oximeter is MUD.

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 K250757Radius VSM 及其附件 K243305馬西莫W1 K240229馬西莫W1

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相關器械（代碼：MUD）

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。

K254129Spectrum-2Neko Health AB K250519Lap.Ox™ 鍋鏡組織氧濃度計ViOptix, Inc.K240596大腦自調節指數（CAI）算法Edwards Lifesciences K241393ODI-TechOdi Medical AS K240601快照NIR型 KD205Kent Imaging, Inc.K232385OxiplexTS200Iss Medical, Inc.

官方來源

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