FDA 510(k)

DEKA SMARTXIDE 触控

K 號：K172362 · 2017-11-17

決定日期2017-11-17

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 TOUCH 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 2017-11-17 under 510(k) number K172362. 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 TOUCH?

DEKA SMARTXIDE TOUCH is a medical device that received FDA 510(k) clearance on 2017-11-17. The listed applicant is El.En Electronic Engineering Spa. The 510(k) number is K172362.

When did DEKA SMARTXIDE TOUCH receive FDA 510(k) clearance?

DEKA SMARTXIDE TOUCH received FDA 510(k) clearance on 2017-11-17, under 510(k) number K172362.

Who is the listed applicant for DEKA SMARTXIDE TOUCH?

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 TOUCH?

The FDA product code for DEKA SMARTXIDE TOUCH is GEX. This falls under the Gastroenterology category.

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