FDA 510(k)

DEKA 摩圖斯 AY

K 號：K181486 · 2018-08-30

決定日期2018-08-30

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 Motus AY 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 2018-08-30 under 510(k) number K181486. 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 Motus AY?

DEKA Motus AY is a medical device that received FDA 510(k) clearance on 2018-08-30. The listed applicant is El.En Electronic Engineering Spa. The 510(k) number is K181486.

When did DEKA Motus AY receive FDA 510(k) clearance?

DEKA Motus AY received FDA 510(k) clearance on 2018-08-30, under 510(k) number K181486.

Who is the listed applicant for DEKA Motus AY?

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 Motus AY?

The FDA product code for DEKA Motus AY is GEX. This falls under the Gastroenterology category.

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