FDA 510(k)

elysion-pro

K号: K193367 · 2020-03-12

决定日期2020-03-12

产品代码GEX

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决定实质等同

器械摘要

elysion-pro is the device name listed in this FDA 510(k) record. The listed applicant is High Technology Products S.L.U. It received FDA 510(k) clearance on 2020-03-12 under 510(k) number K193367. 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 elysion-pro?

elysion-pro is a medical device that received FDA 510(k) clearance on 2020-03-12. The listed applicant is High Technology Products S.L.U. The 510(k) number is K193367.

When did elysion-pro receive FDA 510(k) clearance?

elysion-pro received FDA 510(k) clearance on 2020-03-12, under 510(k) number K193367.

Who is the listed applicant for elysion-pro?

The FDA 510(k) record lists High Technology Products S.L.U as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for elysion-pro?

The FDA product code for elysion-pro is GEX. This falls under the Gastroenterology category.

列明High Technology Products S.L.U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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