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FDA 510(k)

IntelliVue患者监护仪MX100，MX400，MX430，MX450，MX500，MX550，IntelliVue患者监护仪MX700，MX800，IntelliVue患者监护仪MP5，MP5SC，多测量模块X3

K号: K182979 · 2019-11-19

申请人Philips Medizin Systeme Boeblingen GmbH
决定日期2019-11-19
产品代码MHX
咨询委员会CV 请注意，由于原文未提供具体内容，以下是一个示例翻译： --- 产品名称：[产品名称] 公司名称：[公司名称] FDA批准号：[FDA批准号] 510(k)申请号：[510(k)申请号] PMA申请号：[PMA申请号] 临床试验注册号：[NCT] PubMed ID：[PMID] 产品标识符：[标识符] 产品URL：[URL] --- 请将上述示例中的[产品名称]、[公司名称]、[FDA批准号]等占位符替换为实际内容。
决定实质等同

器械摘要

IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient Monitors MX700, MX800, IntelliVue Patient Monitors MP5, MP5SC, Multi-Measurement Module X3 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 2019-11-19 under 510(k) number K182979. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient Monitors MX700, MX800, IntelliVue Patient Monitors MP5, MP5SC, Multi-Measurement Module X3?

IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient Monitors MX700, MX800, IntelliVue Patient Monitors MP5, MP5SC, Multi-Measurement Module X3 is a medical device that received FDA 510(k) clearance on 2019-11-19. The listed applicant is Philips Medizin Systeme Boeblingen GmbH. The 510(k) number is K182979.

When did IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient Monitors MX700, MX800, IntelliVue Patient Monitors MP5, MP5SC, Multi-Measurement Module X3 receive FDA 510(k) clearance?

IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient Monitors MX700, MX800, IntelliVue Patient Monitors MP5, MP5SC, Multi-Measurement Module X3 received FDA 510(k) clearance on 2019-11-19, under 510(k) number K182979.

Who is the listed applicant for IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient Monitors MX700, MX800, IntelliVue Patient Monitors MP5, MP5SC, Multi-Measurement Module X3?

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 Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient Monitors MX700, MX800, IntelliVue Patient Monitors MP5, MP5SC, Multi-Measurement Module X3?

The FDA product code for IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient Monitors MX700, MX800, IntelliVue Patient Monitors MP5, MP5SC, Multi-Measurement Module X3 is MHX.

相关临床试验

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Philips Medizin Systeme Boeblingen GmbH为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K252726IntelliVue 多测量模块 X3 (867030)；IntelliVue 患者监护仪 MX100 (867033)；IntelliVue MMX (867036)K251146IntelliVue患者监护仪MX400，MX450，MX500，MX550K233440Avalon CL胎儿与母亲（F&M）Pod（866488），Avalon CL胎儿与母亲（F&M）贴片（989803196341）K231671IntelliVue患者监护仪MX750（866471），IntelliVue患者监护仪MX850（866470），IntelliVue 4插槽模块架FMX-4（866468）K230604IntelliVue 患者监护仪 MX100 (867033)，IntelliVue 多测量模块 X3 (867030)K223574IntelliVue患者监护仪MX400（866060），IntelliVue患者监护仪MX450（866062），IntelliVue患者监护仪MX500（866064），IntelliVue患者监护仪MX550（866066）

查看所有 20 个设备 →

相关器械（代码：MHX）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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 OyK260343Carescape Canvas 1000；Carescape Canvas智能显示屏GE Healthcare Finland OyK260579Infinity® 急诊护理系统（IACS）- VG8.1Draeger Medical Systems, Inc.K251508遥测监测仪（iT30，iT50）Edan Instruments, Inc.K253277Monitor B105M；Monitor B125M；Monitor B155M；Monitor B105P；Monitor B125PGe Medical Systems Information Technologies, Inc.K254209Radius VSM和附件Masimo Corporation

官方来源

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