FDA 510(k)

V30系统，V-Form手持器BC中型应用器

K号: K162363 · 2016-11-18

决定日期2016-11-18

产品代码GEX

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决定实质等同

器械摘要

V30 system, V-Form Handpiece BC Medium applicator is the device name listed in this FDA 510(k) record. The listed applicant is Viora , Ltd.. It received FDA 510(k) clearance on 2016-11-18 under 510(k) number K162363. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常见问题

What is the V30 system, V-Form Handpiece BC Medium applicator?

V30 system, V-Form Handpiece BC Medium applicator is a medical device that received FDA 510(k) clearance on 2016-11-18. The listed applicant is Viora , Ltd.. The 510(k) number is K162363.

When did V30 system, V-Form Handpiece BC Medium applicator receive FDA 510(k) clearance?

V30 system, V-Form Handpiece BC Medium applicator received FDA 510(k) clearance on 2016-11-18, under 510(k) number K162363.

Who is the listed applicant for V30 system, V-Form Handpiece BC Medium applicator?

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

What is the FDA product code for V30 system, V-Form Handpiece BC Medium applicator?

The FDA product code for V30 system, V-Form Handpiece BC Medium applicator is GEX. This falls under the Gastroenterology category.

列明Viora , Ltd.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。

K202247V30系统，V20系统，V10系统，V-VR手柄 K201064V30系统，V20系统，V10系统，V-FR手柄 K200468V30系统，V20系统，V10系统，V-FC手柄 K152611V20系统

官方来源

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