FDA 510(k)

Universal CMF System

Número K: K221855 · 2022-11-09

RequerenteStryker Leibinger GmbH & Co KG

Data da decisão2022-11-09

Código do produtoJEY

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Universal CMF System is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Leibinger GmbH & Co KG. It received FDA 510(k) clearance on 2022-11-09 under 510(k) number K221855. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Universal CMF System?

Universal CMF System is a medical device that received FDA 510(k) clearance on 2022-11-09. The listed applicant is Stryker Leibinger GmbH & Co KG. The 510(k) number is K221855.

When did Universal CMF System receive FDA 510(k) clearance?

Universal CMF System received FDA 510(k) clearance on 2022-11-09, under 510(k) number K221855.

Who is the listed applicant for Universal CMF System?

The FDA 510(k) record lists Stryker Leibinger GmbH & Co KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Universal CMF System?

The FDA product code for Universal CMF System is JEY.

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Fonte oficial

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