FDA 510(k)

DEKA SMARTXIDE 家族（Smartxide Touch，Smartxide Punto）

K 號：K180193 · 2018-02-21

決定日期2018-02-21

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 SMARTXIDE Family (Smartxide Touch, Smartxide Punto) 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 2018-02-21 under 510(k) number K180193. 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 SMARTXIDE Family (Smartxide Touch, Smartxide Punto)?

DEKA SMARTXIDE Family (Smartxide Touch, Smartxide Punto) is a medical device that received FDA 510(k) clearance on 2018-02-21. The listed applicant is El.En Electronic Engineering Spa. The 510(k) number is K180193.

When did DEKA SMARTXIDE Family (Smartxide Touch, Smartxide Punto) receive FDA 510(k) clearance?

DEKA SMARTXIDE Family (Smartxide Touch, Smartxide Punto) received FDA 510(k) clearance on 2018-02-21, under 510(k) number K180193.

Who is the listed applicant for DEKA SMARTXIDE Family (Smartxide Touch, Smartxide Punto)?

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 SMARTXIDE Family (Smartxide Touch, Smartxide Punto)?

The FDA product code for DEKA SMARTXIDE Family (Smartxide Touch, Smartxide Punto) is GEX. This falls under the Gastroenterology category.

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