FDA 510(k)

AEYE-DS

N.º K: K240058 · 2024-04-23

Fecha de decisión2024-04-23

Código de productoPIB

Comité asesorOP

DecisiónSubstantially Equivalent

Resumen del 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 2024-04-23 under 510(k) number K240058. The device is classified under product code PIB. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the AEYE-DS?

AEYE-DS is a medical device that received FDA 510(k) clearance on 2024-04-23. The listed applicant is Aeye Health, Inc.. The 510(k) number is K240058.

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

AEYE-DS received FDA 510(k) clearance on 2024-04-23, under 510(k) number K240058.

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.

Otros registros que enlistan a Aeye Health, Inc. como solicitante

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K221183AEYE-DS

Dispositivos relacionados (Código: PIB)

K253704iPredict-DRiHealthscreen, Inc.K223357EyeArt v2.2.0Eyenuk, Inc.K221183AEYE-DSAeye Health, Inc.K213037IDx-DR v2.3Digital Diagnostics, Inc.K203629IDx-DRDigital Diagnostics, Inc.K200667EyeArtEyenuk, Inc.

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.