FDA 510(k)

Carescape B850

K 號：K191323 · 2020-01-29

決定日期2020-01-29

產品代碼MHX

諮詢委員會履歷

決定相當於

器材摘要

Carescape B850 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 2020-01-29 under 510(k) number K191323. 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 B850?

Carescape B850 is a medical device that received FDA 510(k) clearance on 2020-01-29. The listed applicant is GE Healthcare Finland Oy. The 510(k) number is K191323.

When did Carescape B850 receive FDA 510(k) clearance?

Carescape B850 received FDA 510(k) clearance on 2020-01-29, under 510(k) number K191323.

Who is the listed applicant for Carescape B850?

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 B850?

The FDA product code for Carescape B850 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 K213181CARESCAPE B650, E-musb K213363CARESCAPE B450, E-musb

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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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