FDA 510(k)

遥测监控 5500 版本 4.0 (867232)

K号: K242962 · 2025-05-05

申请人Philips Medizin Systeme Böblingen GmbH

决定日期2025-05-05

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

Telemetry Monitor 5500 Release 4.0 (867232) is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medizin Systeme Böblingen GmbH. It received FDA 510(k) clearance on 2025-05-05 under 510(k) number K242962. 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 Telemetry Monitor 5500 Release 4.0 (867232)?

Telemetry Monitor 5500 Release 4.0 (867232) is a medical device that received FDA 510(k) clearance on 2025-05-05. The listed applicant is Philips Medizin Systeme Böblingen GmbH. The 510(k) number is K242962.

When did Telemetry Monitor 5500 Release 4.0 (867232) receive FDA 510(k) clearance?

Telemetry Monitor 5500 Release 4.0 (867232) received FDA 510(k) clearance on 2025-05-05, under 510(k) number K242962.

Who is the listed applicant for Telemetry Monitor 5500 Release 4.0 (867232)?

The FDA 510(k) record lists Philips Medizin Systeme Böblingen GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Telemetry Monitor 5500 Release 4.0 (867232)?

The FDA product code for Telemetry Monitor 5500 Release 4.0 (867232) is MHX.

列明Philips Medizin Systeme Böblingen 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。

K252821可重复使用成人SpO2夹式传感器（3m）（M1196A）；可重复使用成人SpO2夹式传感器（0.9m）（M1196T）K253654IntelliVue 测量架 6000 (867317)K251702IntelliVue患者监护仪MX750；IntelliVue患者监护仪MX850；IntelliVue 4插槽模块架FMX-4（866471 866470 866468 ）K250453IntelliVue 患者监护仪 6100 (6100)；IntelliVue 患者监护仪 6300 (6300)；IntelliVue 患者监护仪 6500 (6500)K241890Philips Holter分析系统 K243545Philips可重复使用的ECG导联线和主干电缆：型号编号、型号名称：989803170171，或3导联ECG主干电缆，AAMI/IEC；989803170181，或5导联ECG主干电缆，AAMI/IEC；M1667A，6导联ECG主干，AAMI/IEC 2.7米；M1668A，5导联ECG主干，AAMI/IEC 2.7米；M1669A，3导联ECG主干，AAMI/IEC 2.7米；M1949A，5+5 ECG主干电缆 AAMI，IEC 2.7米；M1663A，10导联ECG主干 AAMI/IEC 2米；M1665A，6+4导联ECG主干 AAMI/IEC 2.7米；M1671A，3导联，抓取器，AAMI，ICU；M1673A，3导联，Sn

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