NIVR58-T套件
K号: K161880 · 2017-03-14
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申请人Barco N.V.
决定日期2017-03-14
产品代码DXJ
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]
---
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
NIVR58-T kit is the device name listed in this FDA 510(k) record. The listed applicant is Barco N.V.. It received FDA 510(k) clearance on 2017-03-14 under 510(k) number K161880. The device is classified under product code DXJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the NIVR58-T kit?
NIVR58-T kit is a medical device that received FDA 510(k) clearance on 2017-03-14. The listed applicant is Barco N.V.. The 510(k) number is K161880.
When did NIVR58-T kit receive FDA 510(k) clearance?
NIVR58-T kit received FDA 510(k) clearance on 2017-03-14, under 510(k) number K161880.
Who is the listed applicant for NIVR58-T kit?
The FDA 510(k) record lists Barco N.V. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for NIVR58-T kit?
The FDA product code for NIVR58-T kit is DXJ.
列明Barco N.V.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：DXJ）
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。
K212003ESSENZ 患者监护仪Livanova Deutschland, GmbHK212208Philips IntelliVue GuardianSoftware（修订版E.0X）Philips Medizin Systeme Boeblingen GmbHK201162Essence 55SP 大型监控系统Shenyang Torch-Bigtide Digital Technology Co., Ltd.K173107维奥斯中央站监护软件，维奥斯中央服务器软件Vios Medical, Inc.K180534Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbHK173381Nexxis 手术室Barco N.V.
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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