FDA 510(k)

ELEMENT-TL

Número K: K180224 · 2018-03-15

Data da decisão2018-03-15

Código do produtoGEX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

ELEMENT-TL is the device name listed in this FDA 510(k) record. The listed applicant is Elemenic Co., Ltd.. It received FDA 510(k) clearance on 2018-03-15 under 510(k) number K180224. 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.

Perguntas frequentes

What is the ELEMENT-TL?

ELEMENT-TL is a medical device that received FDA 510(k) clearance on 2018-03-15. The listed applicant is Elemenic Co., Ltd.. The 510(k) number is K180224.

When did ELEMENT-TL receive FDA 510(k) clearance?

ELEMENT-TL received FDA 510(k) clearance on 2018-03-15, under 510(k) number K180224.

Who is the listed applicant for ELEMENT-TL?

The FDA 510(k) record lists Elemenic Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELEMENT-TL?

The FDA product code for ELEMENT-TL is GEX. This falls under the Gastroenterology category.

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