FDA 510(k)

德卡露絲雅

K 號：K192539 · 2019-12-16

決定日期2019-12-16

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

Deka Luxea is the device name listed in this FDA 510(k) record. The listed applicant is El.En Electronic Engineering Spa. It received FDA 510(k) clearance on 2019-12-16 under 510(k) number K192539. 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 Deka Luxea?

Deka Luxea is a medical device that received FDA 510(k) clearance on 2019-12-16. The listed applicant is El.En Electronic Engineering Spa. The 510(k) number is K192539.

When did Deka Luxea receive FDA 510(k) clearance?

Deka Luxea received FDA 510(k) clearance on 2019-12-16, under 510(k) number K192539.

Who is the listed applicant for Deka Luxea?

The FDA 510(k) record lists El.En Electronic Engineering Spa as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Deka Luxea?

The FDA product code for Deka Luxea is GEX. This falls under the Gastroenterology category.

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