FDA 510(k)

Sistema de Raio Distal do Coto de 2.4mm

Número K: K211324 · 2022-03-14

RequerenteAuxein Medical Private Limited

Data da decisão2022-03-14

Código do produtoHRS

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

2.4mm Distal Radius System is the device name listed in this FDA 510(k) record. The listed applicant is Auxein Medical Private Limited. It received FDA 510(k) clearance on 2022-03-14 under 510(k) number K211324. 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 2.4mm Distal Radius System?

2.4mm Distal Radius System is a medical device that received FDA 510(k) clearance on 2022-03-14. The listed applicant is Auxein Medical Private Limited. The 510(k) number is K211324.

When did 2.4mm Distal Radius System receive FDA 510(k) clearance?

2.4mm Distal Radius System received FDA 510(k) clearance on 2022-03-14, under 510(k) number K211324.

Who is the listed applicant for 2.4mm Distal Radius System?

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

What is the FDA product code for 2.4mm Distal Radius System?

The FDA product code for 2.4mm Distal Radius System is HRS.

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Fonte oficial

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