FDA 510(k)

HALO AP Dx

Número K: K232833 · 2024-05-07

Data da decisão2024-05-07

Código do produtoPSY

Comité consultivoPA

DecisãoSubstantially Equivalent

Resumo do dispositivo

HALO AP Dx is the device name listed in this FDA 510(k) record. The listed applicant is Indica Labs, Inc.. It received FDA 510(k) clearance on 2024-05-07 under 510(k) number K232833. The device is classified under product code PSY. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the HALO AP Dx?

HALO AP Dx is a medical device that received FDA 510(k) clearance on 2024-05-07. The listed applicant is Indica Labs, Inc.. The 510(k) number is K232833.

When did HALO AP Dx receive FDA 510(k) clearance?

HALO AP Dx received FDA 510(k) clearance on 2024-05-07, under 510(k) number K232833.

Who is the listed applicant for HALO AP Dx?

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

What is the FDA product code for HALO AP Dx?

The FDA product code for HALO AP Dx is PSY.

Dispositivos Relacionados (Código: PSY)

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.

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Fonte oficial

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