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FDA 510(k)

IntelliVue病人監護儀MX100及多測量模組X3；intelliVue血流動力學擴充，呼氣末二氧化碳濃度擴充，Microstream擴充；Transpac IV雙通道IBP電纜

K 號：K171801 · 2017-10-06

申請人Philips Medizin Systeme Boeblingen GmbH
決定日期2017-10-06
產品代碼MHX
諮詢委員會履歷
決定相當於

器材摘要

IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic Extension, Capnography Extension, Microstream Extension;Transpac IV Dual IBP Cable 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 2017-10-06 under 510(k) number K171801. 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 MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic Extension, Capnography Extension, Microstream Extension;Transpac IV Dual IBP Cable?

IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic Extension, Capnography Extension, Microstream Extension;Transpac IV Dual IBP Cable is a medical device that received FDA 510(k) clearance on 2017-10-06. The listed applicant is Philips Medizin Systeme Boeblingen GmbH. The 510(k) number is K171801.

When did IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic Extension, Capnography Extension, Microstream Extension;Transpac IV Dual IBP Cable receive FDA 510(k) clearance?

IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic Extension, Capnography Extension, Microstream Extension;Transpac IV Dual IBP Cable received FDA 510(k) clearance on 2017-10-06, under 510(k) number K171801.

Who is the listed applicant for IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic Extension, Capnography Extension, Microstream Extension;Transpac IV Dual IBP Cable?

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 MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic Extension, Capnography Extension, Microstream Extension;Transpac IV Dual IBP Cable?

The FDA product code for IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic Extension, Capnography Extension, Microstream Extension;Transpac IV Dual IBP Cable is MHX.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

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、MX550K233440Avalon 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。

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官方來源

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