FDA 510(k)

AEYE-DS

Número K: K221183 · 2022-11-10

Data da decisão2022-11-10

Código do produtoPIB

Comité consultivoOP

DecisãoSubstantially Equivalent

Resumo do dispositivo

AEYE-DS is the device name listed in this FDA 510(k) record. The listed applicant is Aeye Health, Inc.. It received FDA 510(k) clearance on 2022-11-10 under 510(k) number K221183. The device is classified under product code PIB. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the AEYE-DS?

AEYE-DS is a medical device that received FDA 510(k) clearance on 2022-11-10. The listed applicant is Aeye Health, Inc.. The 510(k) number is K221183.

When did AEYE-DS receive FDA 510(k) clearance?

AEYE-DS received FDA 510(k) clearance on 2022-11-10, under 510(k) number K221183.

Who is the listed applicant for AEYE-DS?

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

What is the FDA product code for AEYE-DS?

The FDA product code for AEYE-DS is PIB.

Outros registros que listam Aeye Health, 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.

K240058AEYE-DS

Dispositivos Relacionados (Código: PIB)

K253704iPredict-DRiHealthscreen, Inc.K240058AEYE-DSAeye Health, Inc.K223357EyeArt v2.2.0Eyenuk, Inc.K213037IDx-DR v2.3Digital Diagnostics, Inc.K203629IDx-DRDigital Diagnostics, Inc.K200667EyeArtEyenuk, Inc.

Fonte oficial

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