FDA 510(k)

ART-Plan

N.º K: K230023 · 2023-04-19

Fecha de decisión2023-04-19

Código de productoQKB

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

ART-Plan is the device name listed in this FDA 510(k) record. The listed applicant is Therapanacea Sas. It received FDA 510(k) clearance on 2023-04-19 under 510(k) number K230023. The device is classified under product code QKB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the ART-Plan?

ART-Plan is a medical device that received FDA 510(k) clearance on 2023-04-19. The listed applicant is Therapanacea Sas. The 510(k) number is K230023.

When did ART-Plan receive FDA 510(k) clearance?

ART-Plan received FDA 510(k) clearance on 2023-04-19, under 510(k) number K230023.

Who is the listed applicant for ART-Plan?

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

What is the FDA product code for ART-Plan?

The FDA product code for ART-Plan is QKB.

Otros registros que enlistan a Therapanacea Sas 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.

K253091ART-Plan+ (v3.1.0)K242822ART-Plan+ (v.3.0.0)K234068ART-Plan (v.2.2.0)

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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.