FDA 510(k)

IB Lab LAMA

Número K: K223646 · 2023-06-16

Data da decisão2023-06-16

Código do produtoQIH

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

IB Lab LAMA is the device name listed in this FDA 510(k) record. The listed applicant is Ib Lab GmbH. It received FDA 510(k) clearance on 2023-06-16 under 510(k) number K223646. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the IB Lab LAMA?

IB Lab LAMA is a medical device that received FDA 510(k) clearance on 2023-06-16. The listed applicant is Ib Lab GmbH. The 510(k) number is K223646.

When did IB Lab LAMA receive FDA 510(k) clearance?

IB Lab LAMA received FDA 510(k) clearance on 2023-06-16, under 510(k) number K223646.

Who is the listed applicant for IB Lab LAMA?

The FDA 510(k) record lists Ib Lab GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IB Lab LAMA?

The FDA product code for IB Lab LAMA is QIH.

Outros registros que listam Ib Lab 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.

K192109KOALA

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Fonte oficial

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