FDA 510(k)

IntelliVue病人監護儀MX500，IntelliVue病人監護儀MX550

K 號：K192137 · 2020-09-11

申請人Philips Medizin Systeme Boeblingen GmbH

決定日期2020-09-11

產品代碼MHX

諮詢委員會履歷

決定相當於

器材摘要

IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550 is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medizin Systeme Boeblingen GmbH. It received FDA 510(k) clearance on 2020-09-11 under 510(k) number K192137. 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 IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550?

IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550 is a medical device that received FDA 510(k) clearance on 2020-09-11. The listed applicant is Philips Medizin Systeme Boeblingen GmbH. The 510(k) number is K192137.

When did IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550 receive FDA 510(k) clearance?

IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550 received FDA 510(k) clearance on 2020-09-11, under 510(k) number K192137.

Who is the listed applicant for IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550?

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

What is the FDA product code for IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550?

The FDA product code for IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550 is MHX.

其他以 Philips Medizin Systeme Boeblingen 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。

K252726IntelliVue 多測量模組 X3 (867030)；IntelliVue 患者監護儀 MX100 (867033)；IntelliVue MMX (867036)K251146IntelliVue 患者監護儀 MX400、MX450、MX500、MX550 K233440Avalon CL 胎兒與母親 (F&M) Pod (866488)，Avalon CL 胎兒與母親 (F&M) 贴片 (989803196341)K231671IntelliVue病人監護儀MX750（866471）、IntelliVue病人監護儀MX850（866470）、IntelliVue 4槽模組架FMX-4（866468）K230604IntelliVue 病患監護儀 MX100 (867033)，IntelliVue 多量測模組 X3 (867030)K223574IntelliVue病人監護儀MX400 (866060)，IntelliVue病人監護儀MX450 (866062)，IntelliVue病人監護儀MX500 (866064)，IntelliVue病人監護儀MX550 (866066)

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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

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