FDA 510(k)

Vivid T8, Vivid T9

N.º K: K181934 · 2018-11-06

SolicitanteGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC

Fecha de decisión2018-11-06

Código de productoIYN

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

Vivid T8, Vivid T9 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 2018-11-06 under 510(k) number K181934. 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 Vivid T8, Vivid T9?

Vivid T8, Vivid T9 is a medical device that received FDA 510(k) clearance on 2018-11-06. The listed applicant is GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC. The 510(k) number is K181934.

When did Vivid T8, Vivid T9 receive FDA 510(k) clearance?

Vivid T8, Vivid T9 received FDA 510(k) clearance on 2018-11-06, under 510(k) number K181934.

Who is the listed applicant for Vivid T8, Vivid T9?

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 Vivid T8, Vivid T9?

The FDA product code for Vivid T8, Vivid T9 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.