FDA 510(k)

IntelliVue 患者监护仪 MX100 (867033)，IntelliVue 多测量模块 X3 (867030)

K号: K230604 · 2023-11-22

申请人Philips Medizin Systeme Boeblingen GmbH

决定日期2023-11-22

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 Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030) 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 2023-11-22 under 510(k) number K230604. 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 Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)?

IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030) is a medical device that received FDA 510(k) clearance on 2023-11-22. The listed applicant is Philips Medizin Systeme Boeblingen GmbH. The 510(k) number is K230604.

When did IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030) receive FDA 510(k) clearance?

IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030) received FDA 510(k) clearance on 2023-11-22, under 510(k) number K230604.

Who is the listed applicant for IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)?

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 (867033), IntelliVue Multi-Measurement Module X3 (867030)?

The FDA product code for IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030) is MHX.

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

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