FDA 510(k)

Sistema de Ultrasonido Diagnóstico ACUSON S3000, Sistema de Ultrasonido Diagnóstico ACUSON S2000

N.º K: K183575 · 2019-03-20

Fecha de decisión2019-03-20

Código de productoIYN

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

ACUSON S3000, S2000 Diagnostic Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthineers. It received FDA 510(k) clearance on 2019-03-20 under 510(k) number K183575. 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 ACUSON S3000, S2000 Diagnostic Ultrasound System?

ACUSON S3000, S2000 Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2019-03-20. The listed applicant is Siemens Healthineers. The 510(k) number is K183575.

When did ACUSON S3000, S2000 Diagnostic Ultrasound System receive FDA 510(k) clearance?

ACUSON S3000, S2000 Diagnostic Ultrasound System received FDA 510(k) clearance on 2019-03-20, under 510(k) number K183575.

Who is the listed applicant for ACUSON S3000, S2000 Diagnostic Ultrasound System?

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

What is the FDA product code for ACUSON S3000, S2000 Diagnostic Ultrasound System?

The FDA product code for ACUSON S3000, S2000 Diagnostic Ultrasound System is IYN.

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Dispositivos relacionados (Código: IYN)

Fuente oficial

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