FDA 510(k)

SherpaPak Lung Preservation System , SherpaPak Liver Transport System

N.º K: K192869 · 2020-01-16

Fecha de decisión2020-01-16

Código de productoKDN

Comité asesorGU

DecisiónUnknown

Resumen del dispositivo

SherpaPak Lung Preservation System , SherpaPak Liver Transport System is the device name listed in this FDA 510(k) record. The listed applicant is Pragonix Technologies. It received FDA 510(k) clearance on 2020-01-16 under 510(k) number K192869. The device is classified under product code KDN. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Preguntas frecuentes

What is the SherpaPak Lung Preservation System , SherpaPak Liver Transport System?

SherpaPak Lung Preservation System , SherpaPak Liver Transport System is a medical device that received FDA 510(k) clearance on 2020-01-16. The listed applicant is Pragonix Technologies. The 510(k) number is K192869.

When did SherpaPak Lung Preservation System , SherpaPak Liver Transport System receive FDA 510(k) clearance?

SherpaPak Lung Preservation System , SherpaPak Liver Transport System received FDA 510(k) clearance on 2020-01-16, under 510(k) number K192869.

Who is the listed applicant for SherpaPak Lung Preservation System , SherpaPak Liver Transport System?

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

What is the FDA product code for SherpaPak Lung Preservation System , SherpaPak Liver Transport System?

The FDA product code for SherpaPak Lung Preservation System , SherpaPak Liver Transport System is KDN.

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Fuente oficial

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Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.