FDA 510(k)

Oxiplex

N.º K: K253326 · 2026-05-01

Fecha de decisión2026-05-01

Código de productoQVL

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Oxiplex is the device name listed in this FDA 510(k) record. The listed applicant is Fziomed, Inc.. It received FDA 510(k) clearance on 2026-05-01 under 510(k) number K253326. The device is classified under product code QVL. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Oxiplex?

Oxiplex is a medical device that received FDA 510(k) clearance on 2026-05-01. The listed applicant is Fziomed, Inc.. The 510(k) number is K253326.

When did Oxiplex receive FDA 510(k) clearance?

Oxiplex received FDA 510(k) clearance on 2026-05-01, under 510(k) number K253326.

Who is the listed applicant for Oxiplex?

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

What is the FDA product code for Oxiplex?

The FDA product code for Oxiplex is QVL.

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