FDA 510(k)

InstaFAN

N.º K: K251542 · 2025-07-18

Fecha de decisión2025-07-18

Código de productoODG

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

InstaFAN is the device name listed in this FDA 510(k) record. The listed applicant is Onepass Medical , Ltd.. It received FDA 510(k) clearance on 2025-07-18 under 510(k) number K251542. The device is classified under product code ODG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the InstaFAN?

InstaFAN is a medical device that received FDA 510(k) clearance on 2025-07-18. The listed applicant is Onepass Medical , Ltd.. The 510(k) number is K251542.

When did InstaFAN receive FDA 510(k) clearance?

InstaFAN received FDA 510(k) clearance on 2025-07-18, under 510(k) number K251542.

Who is the listed applicant for InstaFAN?

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

What is the FDA product code for InstaFAN?

The FDA product code for InstaFAN is ODG.

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Fuente oficial

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