FDA 510(k)

ARIETTA PRECISION

N.º K: K163505 · 2017-05-30

Fecha de decisión2017-05-30

Código de productoIYN

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

ARIETTA PRECISION is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi , Ltd.. It received FDA 510(k) clearance on 2017-05-30 under 510(k) number K163505. 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 ARIETTA PRECISION?

ARIETTA PRECISION is a medical device that received FDA 510(k) clearance on 2017-05-30. The listed applicant is Hitachi , Ltd.. The 510(k) number is K163505.

When did ARIETTA PRECISION receive FDA 510(k) clearance?

ARIETTA PRECISION received FDA 510(k) clearance on 2017-05-30, under 510(k) number K163505.

Who is the listed applicant for ARIETTA PRECISION?

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

What is the FDA product code for ARIETTA PRECISION?

The FDA product code for ARIETTA PRECISION 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.