UbiqVue™ 2AYe 心脏系统（UX2253）
K号: K261569 · 2026-07-09
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决定日期2026-07-09
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：
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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]
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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™ 2AYe Cardiac System (UX2253) is the device name listed in this FDA 510(k) record. The listed applicant is Lifesignals, Inc.. It received FDA 510(k) clearance on 2026-07-09 under 510(k) number K261569. 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™ 2AYe Cardiac System (UX2253)?
UbiqVue™ 2AYe Cardiac System (UX2253) is a medical device that received FDA 510(k) clearance on 2026-07-09. The listed applicant is Lifesignals, Inc.. The 510(k) number is K261569.
When did UbiqVue™ 2AYe Cardiac System (UX2253) receive FDA 510(k) clearance?
UbiqVue™ 2AYe Cardiac System (UX2253) received FDA 510(k) clearance on 2026-07-09, under 510(k) number K261569.
Who is the listed applicant for UbiqVue™ 2AYe Cardiac System (UX2253)?
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™ 2AYe Cardiac System (UX2253)?
The FDA product code for UbiqVue™ 2AYe Cardiac System (UX2253) is DRG.
相关临床试验
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。
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。
相关器械（代码：DRG）
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。
K252984Perin Health System (PHD80060-2)Perin Health Devices, LLCK252440EasyTeleMed (2.0.2)Ingeniars S.R.L.K250259TeleRehab Aermos 心肺康复The ScottCare CorporationK243837iBSMIorbit Digital Technologies Private LimitedK242018UbiqVue™ 2A 多参数系统（UX2550）Lifesignals, Inc.K241101BioButton 系统Biointellisense, Inc.
官方来源
在 FDA 数据库中查看 →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。
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