FDA 510(k)

ART-Plan

N.º K: K202700 · 2021-01-14

Fecha de decisión2021-01-14

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. It received FDA 510(k) clearance on 2021-01-14 under 510(k) number K202700. 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 2021-01-14. The listed applicant is Therapanacea. The 510(k) number is K202700.

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

ART-Plan received FDA 510(k) clearance on 2021-01-14, under 510(k) number K202700.

Who is the listed applicant for ART-Plan?

The FDA 510(k) record lists Therapanacea 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 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.

K232479ART-Plan K220813ART-PLAN

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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.