FDA 510(k)

Elysion-pro

K 號：K193367 · 2020-03-12

決定日期2020-03-12

產品代碼GEX

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

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.

常見問題

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.

其他以 High Technology Products S.L.U 為申請人之記錄

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