FDA 510(k)

Radius VSM 及其附件

K 號：K223498 · 2023-06-01

決定日期2023-06-01

產品代碼MHX

諮詢委員會履歷

決定相當於

器材摘要

Radius VSM 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 2023-06-01 under 510(k) number K223498. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Radius VSM and Accessories?

Radius VSM and Accessories is a medical device that received FDA 510(k) clearance on 2023-06-01. The listed applicant is Masimo Corporation. The 510(k) number is K223498.

When did Radius VSM and Accessories receive FDA 510(k) clearance?

Radius VSM and Accessories received FDA 510(k) clearance on 2023-06-01, under 510(k) number K223498.

Who is the listed applicant for Radius VSM 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 Radius VSM and Accessories?

The FDA product code for Radius VSM and Accessories is MHX.

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：MHX）

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。

K260656Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM 1.8M; TruSignal SpO2 MM 3.0MGE Healthcare Finland Oy K260343Carescape Canvas 1000；Carescape Canvas 智能顯示器GE Healthcare Finland Oy K260579Infinity® 急性照護系統 (IACS) – VG8.1Draeger Medical Systems, Inc.K251508遙測監視器（iT30，iT50）Edan Instruments, Inc.K253277監視器 B105M；監視器 B125M；監視器 B155M；監視器 B105P；監視器 B125PGe Medical Systems Information Technologies, Inc.K254209Radius VSM 及其附件Masimo Corporation

官方來源

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