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FDA 510(k)

Niobe® 磁性导航系统（MNS）与 Navigant 工作站（NWS）和 Cardiodri

K号: K192775 · 2019-10-30

申请人Stereotaxis, Inc.
决定日期2019-10-30
产品代码PJB
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

Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri is the device name listed in this FDA 510(k) record. The listed applicant is Stereotaxis, Inc.. It received FDA 510(k) clearance on 2019-10-30 under 510(k) number K192775. The device is classified under product code PJB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri?

Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri is a medical device that received FDA 510(k) clearance on 2019-10-30. The listed applicant is Stereotaxis, Inc.. The 510(k) number is K192775.

When did Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri receive FDA 510(k) clearance?

Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri received FDA 510(k) clearance on 2019-10-30, under 510(k) number K192775.

Who is the listed applicant for Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri?

FDA 510(k)记录中列出Stereotaxis, Inc.为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri?

The FDA product code for Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri is PJB.

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Stereotaxis, 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。

K262744GenesisX RMNK253473SynchronyK251792Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS)K250590MAGiC Sweep™ EP Mapping CatheterK193147Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive SystemK183027可弯曲导管控制系统

查看所有 7 个设备 →

相关器械（代码：PJB）

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。

K193147Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive SystemStereotaxis, Inc.K183027可弯曲导管控制系统Stereotaxis, Inc.

官方来源

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