FDA 510(k)

维奥斯中央站监护软件，维奥斯中央服务器软件

K号: K173107 · 2018-07-26

决定日期2018-07-26

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： --- 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

Vios Central Station Monitor Software, Vios Central Server Software is the device name listed in this FDA 510(k) record. The listed applicant is Vios Medical, Inc.. It received FDA 510(k) clearance on 2018-07-26 under 510(k) number K173107. 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 Vios Central Station Monitor Software, Vios Central Server Software?

Vios Central Station Monitor Software, Vios Central Server Software is a medical device that received FDA 510(k) clearance on 2018-07-26. The listed applicant is Vios Medical, Inc.. The 510(k) number is K173107.

When did Vios Central Station Monitor Software, Vios Central Server Software receive FDA 510(k) clearance?

Vios Central Station Monitor Software, Vios Central Server Software received FDA 510(k) clearance on 2018-07-26, under 510(k) number K173107.

Who is the listed applicant for Vios Central Station Monitor Software, Vios Central Server Software?

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

What is the FDA product code for Vios Central Station Monitor Software, Vios Central Server Software?

The FDA product code for Vios Central Station Monitor Software, Vios Central Server Software is DXJ.

列明Vios Medical, 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。

K172586Vios监控系统™ 型号2050

官方来源

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