FDA 510(k)

Philips IntelliVue GuardianSoftware

K号: K161767 · 2017-01-27

申请人Philips Medizin Systeme Boeblingen GmbH

决定日期2017-01-27

产品代码DXJ

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

Philips IntelliVue GuardianSoftware 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 2017-01-27 under 510(k) number K161767. The device is classified under product code DXJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Philips IntelliVue GuardianSoftware?

Philips IntelliVue GuardianSoftware is a medical device that received FDA 510(k) clearance on 2017-01-27. The listed applicant is Philips Medizin Systeme Boeblingen GmbH. The 510(k) number is K161767.

When did Philips IntelliVue GuardianSoftware receive FDA 510(k) clearance?

Philips IntelliVue GuardianSoftware received FDA 510(k) clearance on 2017-01-27, under 510(k) number K161767.

Who is the listed applicant for Philips IntelliVue GuardianSoftware?

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 Philips IntelliVue GuardianSoftware?

The FDA product code for Philips IntelliVue GuardianSoftware is DXJ.

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，MX550 K233440Avalon 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 →

官方来源

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