FDA 510(k)

6200 Sistema de Ultrasonido y 6250 Sistema de Ultrasonido

N.º K: K163082 · 2017-03-16

Fecha de decisión2017-03-16

Código de productoIYN

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

6200 Ultrasound System and 6250 Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Esaote, S.p.A.. It received FDA 510(k) clearance on 2017-03-16 under 510(k) number K163082. 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 6200 Ultrasound System and 6250 Ultrasound System?

6200 Ultrasound System and 6250 Ultrasound System is a medical device that received FDA 510(k) clearance on 2017-03-16. The listed applicant is Esaote, S.p.A.. The 510(k) number is K163082.

When did 6200 Ultrasound System and 6250 Ultrasound System receive FDA 510(k) clearance?

6200 Ultrasound System and 6250 Ultrasound System received FDA 510(k) clearance on 2017-03-16, under 510(k) number K163082.

Who is the listed applicant for 6200 Ultrasound System and 6250 Ultrasound System?

The FDA 510(k) record lists Esaote, S.p.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 6200 Ultrasound System and 6250 Ultrasound System?

The FDA product code for 6200 Ultrasound System and 6250 Ultrasound System is IYN.

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Otros registros que enlistan a Esaote, S.p.A. como solicitante

K261331I-Genius (100019400)K253288Sistema de Ultrasonido 6450 (MyLabE80); Sistema de Ultrasonido 6450 (MyLabE85)K260746S-scan Open (100001800)K251901Magnifico Open (100009900)K253310Sistema de Ultrasonido 7600 (MyLabC25); Sistema de Ultrasonido 7600 (MyLabC30)K243253Sistema de Ultrasonido 6600 (MyLabA50); Sistema de Ultrasonido 6600 (MyLabA70)

Ver todos los 25 dispositivos →

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.