FDA 510(k)

Venue

N.º K: K170714 · 2017-06-21

SolicitanteGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC

Fecha de decisión2017-06-21

Código de productoIYN

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

Venue is the device name listed in this FDA 510(k) record. The listed applicant is GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC. It received FDA 510(k) clearance on 2017-06-21 under 510(k) number K170714. 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?

Venue is a medical device that received FDA 510(k) clearance on 2017-06-21. The listed applicant is GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC. The 510(k) number is K170714.

When did Venue receive FDA 510(k) clearance?

Venue received FDA 510(k) clearance on 2017-06-21, under 510(k) number K170714.

Who is the listed applicant for Venue?

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

What is the FDA product code for Venue?

The FDA product code for Venue is IYN.

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Dispositivos relacionados (Código: IYN)

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.