FDA 510(k)

Vydence Zye 和 Vydence One

K号: K202998 · 2021-10-26

申请人Vydence Medical Industria E Comercio Ltda

决定日期2021-10-26

产品代码GEX

咨询委员会SU 请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。

决定实质等同

器械摘要

Vydence Zye and Vydence One is the device name listed in this FDA 510(k) record. The listed applicant is Vydence Medical Industria E Comercio Ltda. It received FDA 510(k) clearance on 2021-10-26 under 510(k) number K202998. 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 Vydence Zye and Vydence One?

Vydence Zye and Vydence One is a medical device that received FDA 510(k) clearance on 2021-10-26. The listed applicant is Vydence Medical Industria E Comercio Ltda. The 510(k) number is K202998.

When did Vydence Zye and Vydence One receive FDA 510(k) clearance?

Vydence Zye and Vydence One received FDA 510(k) clearance on 2021-10-26, under 510(k) number K202998.

Who is the listed applicant for Vydence Zye and Vydence One?

The FDA 510(k) record lists Vydence Medical Industria E Comercio Ltda as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vydence Zye and Vydence One?

The FDA product code for Vydence Zye and Vydence One is GEX. This falls under the Gastroenterology category.

列明Vydence Medical Industria E Comercio Ltda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。

K220041HandPICO K190007Vydence激光系列 K171443Etherea MX

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