FDA 510(k)

CARESCAPE ONE 及 CARESCAPE DOCK FO，CARESCAPE ECG，CARESCAPE TEMP，CARESCAPE PRES

K 號：K200494 · 2020-03-29

決定日期2020-03-29

產品代碼MHX

諮詢委員會履歷

決定相當於

器材摘要

CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRES is the device name listed in this FDA 510(k) record. The listed applicant is GE Healthcare. It received FDA 510(k) clearance on 2020-03-29 under 510(k) number K200494. 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 ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRES?

CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRES is a medical device that received FDA 510(k) clearance on 2020-03-29. The listed applicant is GE Healthcare. The 510(k) number is K200494.

When did CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRES receive FDA 510(k) clearance?

CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRES received FDA 510(k) clearance on 2020-03-29, under 510(k) number K200494.

Who is the listed applicant for CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRES?

The FDA 510(k) record lists GE Healthcare as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRES?

The FDA product code for CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRES is MHX.

其他以 GE Healthcare 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。

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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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