FDA 510(k)

Deka 智能細胞2 三合一

K 號：K181867 · 2018-10-02

決定日期2018-10-02

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 Smartxide2 Trio 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 2018-10-02 under 510(k) number K181867. 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 Smartxide2 Trio?

Deka Smartxide2 Trio is a medical device that received FDA 510(k) clearance on 2018-10-02. The listed applicant is El.En Electronic Engineering Spa. The 510(k) number is K181867.

When did Deka Smartxide2 Trio receive FDA 510(k) clearance?

Deka Smartxide2 Trio received FDA 510(k) clearance on 2018-10-02, under 510(k) number K181867.

Who is the listed applicant for Deka Smartxide2 Trio?

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 Smartxide2 Trio?

The FDA product code for Deka Smartxide2 Trio is GEX. This falls under the Gastroenterology category.

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