FDA 510(k)

Kudu

Número K: K151492 · 2016-05-20

Data da decisão2016-05-20

Código do produtoIOR

Comité consultivoPM

DecisãoSubstantially Equivalent

Resumo do dispositivo

Kudu is the device name listed in this FDA 510(k) record. The listed applicant is R82 A/S. It received FDA 510(k) clearance on 2016-05-20 under 510(k) number K151492. The device is classified under product code IOR. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Kudu?

Kudu is a medical device that received FDA 510(k) clearance on 2016-05-20. The listed applicant is R82 A/S. The 510(k) number is K151492.

When did Kudu receive FDA 510(k) clearance?

Kudu received FDA 510(k) clearance on 2016-05-20, under 510(k) number K151492.

Who is the listed applicant for Kudu?

The FDA 510(k) record lists R82 A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Kudu?

The FDA product code for Kudu is IOR.

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Fonte oficial

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