FDA 510(k)

QF10

N.º K: K261470 · 2026-09-09

Fecha de decisión2026-09-09

Código de productoNHV

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

QF10 is the device name listed in this FDA 510(k) record. The listed applicant is E.A.M Benelux B.V. It received FDA 510(k) clearance on 2026-09-09 under 510(k) number K261470. The device is classified under product code NHV. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the QF10?

QF10 is a medical device that received FDA 510(k) clearance on 2026-09-09. The listed applicant is E.A.M Benelux B.V. The 510(k) number is K261470.

When did QF10 receive FDA 510(k) clearance?

QF10 received FDA 510(k) clearance on 2026-09-09, under 510(k) number K261470.

Who is the listed applicant for QF10?

The FDA 510(k) record lists E.A.M Benelux B.V as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QF10?

The FDA product code for QF10 is NHV.

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Fuente oficial

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Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.