FDA 510(k)

Sistema de Pequeno Fragmento ARIX

Número K: K221920 · 2022-08-24

Data da decisão2022-08-24

Código do produtoHRS

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

ARIX Small Fragment System is the device name listed in this FDA 510(k) record. The listed applicant is Jeil Medical Corporation. It received FDA 510(k) clearance on 2022-08-24 under 510(k) number K221920. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ARIX Small Fragment System?

ARIX Small Fragment System is a medical device that received FDA 510(k) clearance on 2022-08-24. The listed applicant is Jeil Medical Corporation. The 510(k) number is K221920.

When did ARIX Small Fragment System receive FDA 510(k) clearance?

ARIX Small Fragment System received FDA 510(k) clearance on 2022-08-24, under 510(k) number K221920.

Who is the listed applicant for ARIX Small Fragment System?

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

What is the FDA product code for ARIX Small Fragment System?

The FDA product code for ARIX Small Fragment System is HRS.

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Fonte oficial

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