FDA 510(k)

SonoSite Edge II Ultrasound System

N.º K: K153626 · 2016-01-20

Fecha de decisión2016-01-20

Código de productoIYN

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

SonoSite Edge II 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 2016-01-20 under 510(k) number K153626. 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 Edge II Ultrasound System?

SonoSite Edge II Ultrasound System is a medical device that received FDA 510(k) clearance on 2016-01-20. The listed applicant is FUJIFILM Sonosite, Inc.. The 510(k) number is K153626.

When did SonoSite Edge II Ultrasound System receive FDA 510(k) clearance?

SonoSite Edge II Ultrasound System received FDA 510(k) clearance on 2016-01-20, under 510(k) number K153626.

Who is the listed applicant for SonoSite Edge II 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 Edge II Ultrasound System?

The FDA product code for SonoSite Edge II 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.