FDA 510(k)

7410 Sistema de Ultrasonido (MyLabSigma)

N.º K: K191072 · 2019-06-10

Fecha de decisión2019-06-10

Código de productoIYN

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

7410 Ultrasound System (MyLabSigma) 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 2019-06-10 under 510(k) number K191072. 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 7410 Ultrasound System (MyLabSigma)?

7410 Ultrasound System (MyLabSigma) is a medical device that received FDA 510(k) clearance on 2019-06-10. The listed applicant is Esaote, S.p.A.. The 510(k) number is K191072.

When did 7410 Ultrasound System (MyLabSigma) receive FDA 510(k) clearance?

7410 Ultrasound System (MyLabSigma) received FDA 510(k) clearance on 2019-06-10, under 510(k) number K191072.

Who is the listed applicant for 7410 Ultrasound System (MyLabSigma)?

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 7410 Ultrasound System (MyLabSigma)?

The FDA product code for 7410 Ultrasound System (MyLabSigma) 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.