FDA 510(k)

IntraMarX 3D Radiopaque Marker

Número K: K201106 · 2020-05-21

Data da decisão2020-05-21

Código do produtoFFX

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

IntraMarX 3D Radiopaque Marker is the device name listed in this FDA 510(k) record. The listed applicant is Anx Robotica Corp. It received FDA 510(k) clearance on 2020-05-21 under 510(k) number K201106. The device is classified under product code FFX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the IntraMarX 3D Radiopaque Marker?

IntraMarX 3D Radiopaque Marker is a medical device that received FDA 510(k) clearance on 2020-05-21. The listed applicant is Anx Robotica Corp. The 510(k) number is K201106.

When did IntraMarX 3D Radiopaque Marker receive FDA 510(k) clearance?

IntraMarX 3D Radiopaque Marker received FDA 510(k) clearance on 2020-05-21, under 510(k) number K201106.

Who is the listed applicant for IntraMarX 3D Radiopaque Marker?

The FDA 510(k) record lists Anx Robotica Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IntraMarX 3D Radiopaque Marker?

The FDA product code for IntraMarX 3D Radiopaque Marker is FFX.

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Outros registros que listam Anx Robotica Corp como candidato(a)

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