FDA 510(k)

ANDI 2.0

Número K: K252298 · 2025-10-22

Data da decisão2025-10-22

Código do produtoQIH

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

ANDI 2.0 is the device name listed in this FDA 510(k) record. The listed applicant is Imeka Solutions, Inc.. It received FDA 510(k) clearance on 2025-10-22 under 510(k) number K252298. 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 ANDI 2.0?

ANDI 2.0 is a medical device that received FDA 510(k) clearance on 2025-10-22. The listed applicant is Imeka Solutions, Inc.. The 510(k) number is K252298.

When did ANDI 2.0 receive FDA 510(k) clearance?

ANDI 2.0 received FDA 510(k) clearance on 2025-10-22, under 510(k) number K252298.

Who is the listed applicant for ANDI 2.0?

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

What is the FDA product code for ANDI 2.0?

The FDA product code for ANDI 2.0 is QIH.

Outros registros que listam Imeka Solutions, Inc. 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.

K261405ANDI 2.2 K230913ANDI

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Fonte oficial

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