FDA 510(k)

Impress SFS System

Número K: K173910 · 2018-09-14

Data da decisão2018-09-14

Código do produtoJDQ

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Impress SFS System is the device name listed in this FDA 510(k) record. The listed applicant is Cable Fix Medical, LLC. It received FDA 510(k) clearance on 2018-09-14 under 510(k) number K173910. The device is classified under product code JDQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Impress SFS System?

Impress SFS System is a medical device that received FDA 510(k) clearance on 2018-09-14. The listed applicant is Cable Fix Medical, LLC. The 510(k) number is K173910.

When did Impress SFS System receive FDA 510(k) clearance?

Impress SFS System received FDA 510(k) clearance on 2018-09-14, under 510(k) number K173910.

Who is the listed applicant for Impress SFS System?

The FDA 510(k) record lists Cable Fix Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Impress SFS System?

The FDA product code for Impress SFS System is JDQ.

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