FDA 510(k)

V30系统，V20系统，V10系统，V-FR手柄

K号: K201064 · 2020-07-15

决定日期2020-07-15

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-FR 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 2020-07-15 under 510(k) number K201064. 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-FR Handpiece?

V30 System, V20 System, V10 System, V-FR Handpiece is a medical device that received FDA 510(k) clearance on 2020-07-15. The listed applicant is Viora , Ltd.. The 510(k) number is K201064.

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

V30 System, V20 System, V10 System, V-FR Handpiece received FDA 510(k) clearance on 2020-07-15, under 510(k) number K201064.

Who is the listed applicant for V30 System, V20 System, V10 System, V-FR 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-FR Handpiece?

The FDA product code for V30 System, V20 System, V10 System, V-FR 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 K200468V30系统，V20系统，V10系统，V-FC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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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。