FDA 510(k)

MT ONE

Número K: K172413 · 2017-10-06

Data da decisão2017-10-06

Código do produtoGEX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

MT ONE is the device name listed in this FDA 510(k) record. The listed applicant is M&T S.R.L.. It received FDA 510(k) clearance on 2017-10-06 under 510(k) number K172413. 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 MT ONE?

MT ONE is a medical device that received FDA 510(k) clearance on 2017-10-06. The listed applicant is M&T S.R.L.. The 510(k) number is K172413.

When did MT ONE receive FDA 510(k) clearance?

MT ONE received FDA 510(k) clearance on 2017-10-06, under 510(k) number K172413.

Who is the listed applicant for MT ONE?

The FDA 510(k) record lists M&T S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MT ONE?

The FDA product code for MT ONE is GEX. This falls under the Gastroenterology category.

Outros registros que listam M&T S.R.L. como candidato(a)

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

K240604MTONE EVO (MTONE EVO)K192856MT One K191942MT One Diamond

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Fonte oficial

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