FDA 510(k)

Vlab

Número K: K230148 · 2023-10-11

Data da decisão2023-10-11

Código do produtoGWL

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Vlab is the device name listed in this FDA 510(k) record. The listed applicant is Dormotech Medical, Ltd.. It received FDA 510(k) clearance on 2023-10-11 under 510(k) number K230148. The device is classified under product code GWL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Vlab?

Vlab is a medical device that received FDA 510(k) clearance on 2023-10-11. The listed applicant is Dormotech Medical, Ltd.. The 510(k) number is K230148.

When did Vlab receive FDA 510(k) clearance?

Vlab received FDA 510(k) clearance on 2023-10-11, under 510(k) number K230148.

Who is the listed applicant for Vlab?

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

What is the FDA product code for Vlab?

The FDA product code for Vlab is GWL.

Outros registros que listam Dormotech Medical, Ltd. 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.

K242290DormoTech NLab

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Fonte oficial

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