FDA 510(k)

無限急症護理系統（IACS）監控方案

K 號：K201764 · 2021-12-09

決定日期2021-12-09

產品代碼MHX

諮詢委員會履歷

決定相當於

器材摘要

Infinity Acute Care System (IACS) Monitoring Solution is the device name listed in this FDA 510(k) record. The listed applicant is Draeger Medical Systems, Inc.. It received FDA 510(k) clearance on 2021-12-09 under 510(k) number K201764. 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 Infinity Acute Care System (IACS) Monitoring Solution?

Infinity Acute Care System (IACS) Monitoring Solution is a medical device that received FDA 510(k) clearance on 2021-12-09. The listed applicant is Draeger Medical Systems, Inc.. The 510(k) number is K201764.

When did Infinity Acute Care System (IACS) Monitoring Solution receive FDA 510(k) clearance?

Infinity Acute Care System (IACS) Monitoring Solution received FDA 510(k) clearance on 2021-12-09, under 510(k) number K201764.

Who is the listed applicant for Infinity Acute Care System (IACS) Monitoring Solution?

FDA 510(k) 記錄將 Draeger Medical Systems, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Infinity Acute Care System (IACS) Monitoring Solution?

The FDA product code for Infinity Acute Care System (IACS) Monitoring Solution is MHX.

其他以 Draeger Medical Systems, Inc. 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。

K260579Infinity® 急性照護系統 (IACS) – VG8.1 K243606Babyroo TN300 K240312無限中央站廣域 K233834無限門戶套件 K231477無限中央站廣域版，無限M300，無限M300+K230278Babyroo TN300

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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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