FDA 510(k)

3D-Cut

N.º K: K212237 · 2021-11-29

Fecha de decisión2021-11-29

Código de productoPBF

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

3D-Cut is the device name listed in this FDA 510(k) record. The listed applicant is 3D-Side S.A.. It received FDA 510(k) clearance on 2021-11-29 under 510(k) number K212237. The device is classified under product code PBF. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the 3D-Cut?

3D-Cut is a medical device that received FDA 510(k) clearance on 2021-11-29. The listed applicant is 3D-Side S.A.. The 510(k) number is K212237.

When did 3D-Cut receive FDA 510(k) clearance?

3D-Cut received FDA 510(k) clearance on 2021-11-29, under 510(k) number K212237.

Who is the listed applicant for 3D-Cut?

The FDA 510(k) record lists 3D-Side S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3D-Cut?

The FDA product code for 3D-Cut is PBF.

Otros registros que enlistan a 3D-Side S.A. 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.

K221432Customize K213779Customize

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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.