FDA 510(k)

UbiqVue™ 2A 多参数系统（UX2550）

K号: K242018 · 2024-11-12

决定日期2024-11-12

产品代码DRG

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

UbiqVue™ 2A Multi-parameter System (UX2550) is the device name listed in this FDA 510(k) record. The listed applicant is Lifesignals, Inc.. It received FDA 510(k) clearance on 2024-11-12 under 510(k) number K242018. The device is classified under product code DRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the UbiqVue™ 2A Multi-parameter System (UX2550)?

UbiqVue™ 2A Multi-parameter System (UX2550) is a medical device that received FDA 510(k) clearance on 2024-11-12. The listed applicant is Lifesignals, Inc.. The 510(k) number is K242018.

When did UbiqVue™ 2A Multi-parameter System (UX2550) receive FDA 510(k) clearance?

UbiqVue™ 2A Multi-parameter System (UX2550) received FDA 510(k) clearance on 2024-11-12, under 510(k) number K242018.

Who is the listed applicant for UbiqVue™ 2A Multi-parameter System (UX2550)?

The FDA 510(k) record lists Lifesignals, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UbiqVue™ 2A Multi-parameter System (UX2550)?

The FDA product code for UbiqVue™ 2A Multi-parameter System (UX2550) is DRG.

列明Lifesignals, Inc.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。

K261569UbiqVue™ 2AYe 心脏系统（UX2253）K202868LifeSignals 多参数远程监测平台 K200690LifeSignals ECG 远程监测贴片平台

官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。