FDA 510(k)

Venue Go

N.º K: K261668 · 2026-08-07

SolicitanteGE Medical Systems Ultrasound and Primary care Diagnostics, LLC

Fecha de decisión2026-08-07

Código de productoIYN

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

Venue Go is the device name listed in this FDA 510(k) record. The listed applicant is GE Medical Systems Ultrasound and Primary care Diagnostics, LLC. It received FDA 510(k) clearance on 2026-08-07 under 510(k) number K261668. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Venue Go?

Venue Go is a medical device that received FDA 510(k) clearance on 2026-08-07. The listed applicant is GE Medical Systems Ultrasound and Primary care Diagnostics, LLC. The 510(k) number is K261668.

When did Venue Go receive FDA 510(k) clearance?

Venue Go received FDA 510(k) clearance on 2026-08-07, under 510(k) number K261668.

Who is the listed applicant for Venue Go?

The FDA 510(k) record lists GE Medical Systems Ultrasound and Primary care Diagnostics, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Venue Go?

The FDA product code for Venue Go is IYN.

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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.