FDA 510(k)

Wolf445nm

Número K: K192272 · 2020-03-17

Data da decisão2020-03-17

Código do produtoGEX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Wolf445nm is the device name listed in this FDA 510(k) record. The listed applicant is A.R.C Laser GmbH. It received FDA 510(k) clearance on 2020-03-17 under 510(k) number K192272. 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 Wolf445nm?

Wolf445nm is a medical device that received FDA 510(k) clearance on 2020-03-17. The listed applicant is A.R.C Laser GmbH. The 510(k) number is K192272.

When did Wolf445nm receive FDA 510(k) clearance?

Wolf445nm received FDA 510(k) clearance on 2020-03-17, under 510(k) number K192272.

Who is the listed applicant for Wolf445nm?

The FDA 510(k) record lists A.R.C Laser GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Wolf445nm?

The FDA product code for Wolf445nm is GEX. This falls under the Gastroenterology category.

Outros registros que listam A.R.C Laser GmbH 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.

K220531FOX 810, FOX 980 K170183Cetus system, Cetus probe K161403Fibras e Probes Cirúrgicas a Laser A.R.C.

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Fonte oficial

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