FDA 510(k)

IntelliVue 肺泡图扩展，IntelliVue Microstream 扩展

K号: K172904 · 2017-12-26

申请人Philips Medizin Systeme Boeblingen GmbH

决定日期2017-12-26

产品代码CCK

咨询委员会AN 请注意，由于您没有提供完整的医疗设备监管文本，我无法提供完整的翻译。如果您能提供完整的文本，我将很乐意为您翻译。

决定实质等同

器械摘要

IntelliVue Capnography Extension, IntelliVue Microstream Extension 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 2017-12-26 under 510(k) number K172904. The device is classified under product code CCK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the IntelliVue Capnography Extension, IntelliVue Microstream Extension?

IntelliVue Capnography Extension, IntelliVue Microstream Extension is a medical device that received FDA 510(k) clearance on 2017-12-26. The listed applicant is Philips Medizin Systeme Boeblingen GmbH. The 510(k) number is K172904.

When did IntelliVue Capnography Extension, IntelliVue Microstream Extension receive FDA 510(k) clearance?

IntelliVue Capnography Extension, IntelliVue Microstream Extension received FDA 510(k) clearance on 2017-12-26, under 510(k) number K172904.

Who is the listed applicant for IntelliVue Capnography Extension, IntelliVue Microstream Extension?

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 Capnography Extension, IntelliVue Microstream Extension?

The FDA product code for IntelliVue Capnography Extension, IntelliVue Microstream Extension is CCK.

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）

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官方来源

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