FDA 510(k)

ClearLine IV

Número K: K171954 · 2018-01-25

Data da decisão2018-01-25

Código do produtoOKL

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

ClearLine IV is the device name listed in this FDA 510(k) record. The listed applicant is Clearline MD. It received FDA 510(k) clearance on 2018-01-25 under 510(k) number K171954. The device is classified under product code OKL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ClearLine IV?

ClearLine IV is a medical device that received FDA 510(k) clearance on 2018-01-25. The listed applicant is Clearline MD. The 510(k) number is K171954.

When did ClearLine IV receive FDA 510(k) clearance?

ClearLine IV received FDA 510(k) clearance on 2018-01-25, under 510(k) number K171954.

Who is the listed applicant for ClearLine IV?

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

What is the FDA product code for ClearLine IV?

The FDA product code for ClearLine IV is OKL.

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