Nexxis OR, Nexxis
K号: K170537 · 2017-04-21
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申请人Barco N.V.
决定日期2017-04-21
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
Nexxis OR, Nexxis 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 2017-04-21 under 510(k) number K170537. 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 Nexxis OR, Nexxis?
Nexxis OR, Nexxis is a medical device that received FDA 510(k) clearance on 2017-04-21. The listed applicant is Barco N.V.. The 510(k) number is K170537.
When did Nexxis OR, Nexxis receive FDA 510(k) clearance?
Nexxis OR, Nexxis received FDA 510(k) clearance on 2017-04-21, under 510(k) number K170537.
Who is the listed applicant for Nexxis OR, Nexxis?
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 Nexxis OR, Nexxis?
The FDA product code for Nexxis OR, Nexxis is DXJ.
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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