FDA 510(k)

VITA VIONIC Bond

N.º K: K191926 · 2020-01-29

SolicitanteVita Zanhnfabrik H. Rauter GmbH Co.

Fecha de decisión2020-01-29

Código de productoEBI

Comité asesorDE

DecisiónSubstantially Equivalent

Resumen del dispositivo

VITA VIONIC Bond is the device name listed in this FDA 510(k) record. The listed applicant is Vita Zanhnfabrik H. Rauter GmbH Co.. It received FDA 510(k) clearance on 2020-01-29 under 510(k) number K191926. 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 VITA VIONIC Bond?

VITA VIONIC Bond is a medical device that received FDA 510(k) clearance on 2020-01-29. The listed applicant is Vita Zanhnfabrik H. Rauter GmbH Co.. The 510(k) number is K191926.

When did VITA VIONIC Bond receive FDA 510(k) clearance?

VITA VIONIC Bond received FDA 510(k) clearance on 2020-01-29, under 510(k) number K191926.

Who is the listed applicant for VITA VIONIC Bond?

The FDA 510(k) record lists Vita Zanhnfabrik H. Rauter GmbH Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VITA VIONIC Bond?

The FDA product code for VITA VIONIC Bond is EBI.

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Fuente oficial

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