FDA 510(k)

EVO 平台

K号: K160368 · 2016-04-05

决定日期2016-04-05

产品代码GEX

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决定实质等同

器械摘要

EVO platform is the device name listed in this FDA 510(k) record. The listed applicant is Quanta System Spa. It received FDA 510(k) clearance on 2016-04-05 under 510(k) number K160368. 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 EVO platform?

EVO platform is a medical device that received FDA 510(k) clearance on 2016-04-05. The listed applicant is Quanta System Spa. The 510(k) number is K160368.

When did EVO platform receive FDA 510(k) clearance?

EVO platform received FDA 510(k) clearance on 2016-04-05, under 510(k) number K160368.

Who is the listed applicant for EVO platform?

The FDA 510(k) record lists Quanta System Spa as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EVO platform?

The FDA product code for EVO platform is GEX. This falls under the Gastroenterology category.

列明Quanta System Spa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。

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官方来源

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