FDA 510(k)

DiviTum TKa

Número K: K202852 · 2022-07-29

Data da decisão2022-07-29

Código do produtoQTE

Comité consultivoIM

DecisãoSubstantially Equivalent

Resumo do dispositivo

DiviTum TKa is the device name listed in this FDA 510(k) record. The listed applicant is Biovica International AB. It received FDA 510(k) clearance on 2022-07-29 under 510(k) number K202852. The device is classified under product code QTE. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the DiviTum TKa?

DiviTum TKa is a medical device that received FDA 510(k) clearance on 2022-07-29. The listed applicant is Biovica International AB. The 510(k) number is K202852.

When did DiviTum TKa receive FDA 510(k) clearance?

DiviTum TKa received FDA 510(k) clearance on 2022-07-29, under 510(k) number K202852.

Who is the listed applicant for DiviTum TKa?

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

What is the FDA product code for DiviTum TKa?

The FDA product code for DiviTum TKa is QTE.

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