FDA 510(k)

FP3D

N.º K: K250489 · 2025-05-20

Fecha de decisión2025-05-20

Código de productoEBI

Comité asesorDE

DecisiónSubstantially Equivalent

Resumen del dispositivo

FP3D is the device name listed in this FDA 510(k) record. The listed applicant is Keystone Industries. It received FDA 510(k) clearance on 2025-05-20 under 510(k) number K250489. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the FP3D?

FP3D is a medical device that received FDA 510(k) clearance on 2025-05-20. The listed applicant is Keystone Industries. The 510(k) number is K250489.

When did FP3D receive FDA 510(k) clearance?

FP3D received FDA 510(k) clearance on 2025-05-20, under 510(k) number K250489.

Who is the listed applicant for FP3D?

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

What is the FDA product code for FP3D?

The FDA product code for FP3D is EBI.

Otros registros que enlistan a Keystone Industries 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.

K241089KeyPrint KeyDenture Base K183598KeyPrint KeySplint Soft

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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.