FDA 510(k)

病人資訊中心iX

K 號：K211900 · 2022-03-04

申請人Philips Medizin Systeme Böblingen GmbH

決定日期2022-03-04

產品代碼MHX

諮詢委員會履歷

決定相當於

器材摘要

Patient Information Center iX is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medizin Systeme Böblingen GmbH. It received FDA 510(k) clearance on 2022-03-04 under 510(k) number K211900. 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 Patient Information Center iX?

Patient Information Center iX is a medical device that received FDA 510(k) clearance on 2022-03-04. The listed applicant is Philips Medizin Systeme Böblingen GmbH. The 510(k) number is K211900.

When did Patient Information Center iX receive FDA 510(k) clearance?

Patient Information Center iX received FDA 510(k) clearance on 2022-03-04, under 510(k) number K211900.

Who is the listed applicant for Patient Information Center iX?

The FDA 510(k) record lists Philips Medizin Systeme Böblingen GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Patient Information Center iX?

The FDA product code for Patient Information Center iX is MHX.

其他以 Philips Medizin Systeme Böblingen GmbH 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。

K252821可重用成人SpO2夾式感測器（3m）（M1196A）；可重用成人SpO2夾式感測器（0.9m）（M1196T）K253654IntelliVue測量架6000（867317）K251702IntelliVue病人監護儀MX750；IntelliVue病人監護儀MX850；IntelliVue 4槽模組架FMX-4（866471 866470 866468）K250453IntelliVue病人監護儀6100（6100）；IntelliVue病人監護儀6300（6300）；IntelliVue病人監護儀6500（6500）K242962遙測監視器 5500 版本 4.0 (867232)K241890飛利浦心電圖分析系統

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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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