FDA 510(k)

Monteris Medical NeuroBlate System

Número K: K171255 · 2017-07-25

Data da decisão2017-07-25

Código do produtoGEX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Monteris Medical NeuroBlate System is the device name listed in this FDA 510(k) record. The listed applicant is Monteris Medical, Inc.. It received FDA 510(k) clearance on 2017-07-25 under 510(k) number K171255. 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 Monteris Medical NeuroBlate System?

Monteris Medical NeuroBlate System is a medical device that received FDA 510(k) clearance on 2017-07-25. The listed applicant is Monteris Medical, Inc.. The 510(k) number is K171255.

When did Monteris Medical NeuroBlate System receive FDA 510(k) clearance?

Monteris Medical NeuroBlate System received FDA 510(k) clearance on 2017-07-25, under 510(k) number K171255.

Who is the listed applicant for Monteris Medical NeuroBlate System?

The FDA 510(k) record lists Monteris Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Monteris Medical NeuroBlate System?

The FDA product code for Monteris Medical NeuroBlate System is GEX. This falls under the Gastroenterology category.

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Outros registros que listam Monteris Medical, Inc. como candidato(a)

K201056NeuroBlate System K162762NeuroBlate System

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Fonte oficial

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