FDA 510(k)

PreferX Delivery System

Número K: K210997 · 2021-09-07

Data da decisão2021-09-07

Código do produtoFMF

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

PreferX Delivery System is the device name listed in this FDA 510(k) record. The listed applicant is Md3, LLC. It received FDA 510(k) clearance on 2021-09-07 under 510(k) number K210997. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the PreferX Delivery System?

PreferX Delivery System is a medical device that received FDA 510(k) clearance on 2021-09-07. The listed applicant is Md3, LLC. The 510(k) number is K210997.

When did PreferX Delivery System receive FDA 510(k) clearance?

PreferX Delivery System received FDA 510(k) clearance on 2021-09-07, under 510(k) number K210997.

Who is the listed applicant for PreferX Delivery System?

The FDA 510(k) record lists Md3, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PreferX Delivery System?

The FDA product code for PreferX Delivery System is FMF.

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Fonte oficial

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