FDA 510(k)

DiviTum TKa

N.º K: K202852 · 2022-07-29

Fecha de decisión2022-07-29

Código de productoQTE

Comité asesorIM

DecisiónSubstantially Equivalent

Resumen del 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.

Preguntas frecuentes

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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Fuente oficial

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