FDA 510(k)

CARESCAPE B650, E-musb

K 號：K213181 · 2022-04-13

決定日期2022-04-13

產品代碼MHX

諮詢委員會履歷

決定相當於

器材摘要

CARESCAPE B650, E-musb is the device name listed in this FDA 510(k) record. The listed applicant is GE Healthcare Finland Oy. It received FDA 510(k) clearance on 2022-04-13 under 510(k) number K213181. 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 CARESCAPE B650, E-musb?

CARESCAPE B650, E-musb is a medical device that received FDA 510(k) clearance on 2022-04-13. The listed applicant is GE Healthcare Finland Oy. The 510(k) number is K213181.

When did CARESCAPE B650, E-musb receive FDA 510(k) clearance?

CARESCAPE B650, E-musb received FDA 510(k) clearance on 2022-04-13, under 510(k) number K213181.

Who is the listed applicant for CARESCAPE B650, E-musb?

FDA 510(k) 記錄將 GE Healthcare Finland Oy 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for CARESCAPE B650, E-musb?

The FDA product code for CARESCAPE B650, E-musb is MHX.

其他以 GE Healthcare Finland Oy 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。

K260656Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM 1.8M; TruSignal SpO2 MM 3.0M K260343Carescape Canvas 1000；Carescape Canvas 智能顯示器 K223531CARESCAPE Canvas 1000、CARESCAPE Canvas Smart Display、CARESCAPE Canvas D19、F2 框架（F2-01）K213336Carescape B850, E-musb K213363CARESCAPE B450, E-musb K211171CARESCAPE 呼吸模組 E-sCO、E-sCOV、E-sCOVX、E-sCAiO、E-sCAiOV、E-sCAiOVX、E-sCAiOE、E-sCAiOVE 及相關配件

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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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