FDA 510(k)

Sonosite PX Ultrasound System

N.º K: K200964 · 2020-05-08

Fecha de decisión2020-05-08

Código de productoIYN

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

Sonosite PX Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is FUJIFILM Sonosite, Inc.. It received FDA 510(k) clearance on 2020-05-08 under 510(k) number K200964. 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 Sonosite PX Ultrasound System?

Sonosite PX Ultrasound System is a medical device that received FDA 510(k) clearance on 2020-05-08. The listed applicant is FUJIFILM Sonosite, Inc.. The 510(k) number is K200964.

When did Sonosite PX Ultrasound System receive FDA 510(k) clearance?

Sonosite PX Ultrasound System received FDA 510(k) clearance on 2020-05-08, under 510(k) number K200964.

Who is the listed applicant for Sonosite PX Ultrasound System?

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

What is the FDA product code for Sonosite PX Ultrasound System?

The FDA product code for Sonosite PX Ultrasound System is IYN.

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Otros registros que enlistan a FUJIFILM Sonosite, Inc. como solicitante

K260595Sonosite iLOOK Ultrasound System K253448Sonosite MT Ultrasound System K251106Sonosite LX and Sonosite PX Ultrasound Systems K251830Sonosite LX Ultrasound System K233597Sonosite LX Ultrasound System K213763Sonosite PX Ultrasound System

Ver todos los 19 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.