FDA 510(k)

V30系统，V20系统，V10系统，V-FC手柄

K号: K200468 · 2020-05-21

决定日期2020-05-21

产品代码PBX

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决定实质等同

器械摘要

V30 system, V20 system, V10 system, V-FC Handpiece is the device name listed in this FDA 510(k) record. The listed applicant is Viora , Ltd.. It received FDA 510(k) clearance on 2020-05-21 under 510(k) number K200468. The device is classified under product code PBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the V30 system, V20 system, V10 system, V-FC Handpiece?

V30 system, V20 system, V10 system, V-FC Handpiece is a medical device that received FDA 510(k) clearance on 2020-05-21. The listed applicant is Viora , Ltd.. The 510(k) number is K200468.

When did V30 system, V20 system, V10 system, V-FC Handpiece receive FDA 510(k) clearance?

V30 system, V20 system, V10 system, V-FC Handpiece received FDA 510(k) clearance on 2020-05-21, under 510(k) number K200468.

Who is the listed applicant for V30 system, V20 system, V10 system, V-FC Handpiece?

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, V20 system, V10 system, V-FC Handpiece?

The FDA product code for V30 system, V20 system, V10 system, V-FC Handpiece is PBX.

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 K162363V30系统，V-Form手持器BC中型应用器 K152611V20系统

官方来源

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