FDA 510(k)

eLyx-PRO

K 號：K162851 · 2017-01-24

決定日期2017-01-24

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

eLyx-PRO is the device name listed in this FDA 510(k) record. The listed applicant is Intelligent Sensory Concept SA. It received FDA 510(k) clearance on 2017-01-24 under 510(k) number K162851. 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 eLyx-PRO?

eLyx-PRO is a medical device that received FDA 510(k) clearance on 2017-01-24. The listed applicant is Intelligent Sensory Concept SA. The 510(k) number is K162851.

When did eLyx-PRO receive FDA 510(k) clearance?

eLyx-PRO received FDA 510(k) clearance on 2017-01-24, under 510(k) number K162851.

Who is the listed applicant for eLyx-PRO?

The FDA 510(k) record lists Intelligent Sensory Concept SA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for eLyx-PRO?

The FDA product code for eLyx-PRO is GEX. This falls under the Gastroenterology category.

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