FDA 510(k)

C Scope Visualization System

Número K: K203526 · 2021-01-12

Data da decisão2021-01-12

Código do produtoHRX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

C Scope Visualization System is the device name listed in this FDA 510(k) record. The listed applicant is Cit Ortho. It received FDA 510(k) clearance on 2021-01-12 under 510(k) number K203526. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the C Scope Visualization System?

C Scope Visualization System is a medical device that received FDA 510(k) clearance on 2021-01-12. The listed applicant is Cit Ortho. The 510(k) number is K203526.

When did C Scope Visualization System receive FDA 510(k) clearance?

C Scope Visualization System received FDA 510(k) clearance on 2021-01-12, under 510(k) number K203526.

Who is the listed applicant for C Scope Visualization System?

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

What is the FDA product code for C Scope Visualization System?

The FDA product code for C Scope Visualization System is HRX.

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