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FDA 510(k)

IV-eye

N.º K: K152088 · 2016-02-24

SolicitanteNovarix Limited
Fecha de decisión2016-02-24
Código de productoKZA
Comité asesorHO
DecisiónSubstantially Equivalent

Resumen del dispositivo

IV-eye is the device name listed in this FDA 510(k) record. The listed applicant is Novarix Limited. It received FDA 510(k) clearance on 2016-02-24 under 510(k) number K152088. The device is classified under product code KZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the IV-eye?

IV-eye is a medical device that received FDA 510(k) clearance on 2016-02-24. The listed applicant is Novarix Limited. The 510(k) number is K152088.

When did IV-eye receive FDA 510(k) clearance?

IV-eye received FDA 510(k) clearance on 2016-02-24, under 510(k) number K152088.

Who is the listed applicant for IV-eye?

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

What is the FDA product code for IV-eye?

The FDA product code for IV-eye is KZA.

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.

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