FDA 510(k)

MRI Universal

Número K: K240651 · 2024-07-12

RequerenteStryker Leibinger GmbH & Co KG

Data da decisão2024-07-12

Código do produtoJEY

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

MRI Universal 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 2024-07-12 under 510(k) number K240651. 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 MRI Universal?

MRI Universal is a medical device that received FDA 510(k) clearance on 2024-07-12. The listed applicant is Stryker Leibinger GmbH & Co KG. The 510(k) number is K240651.

When did MRI Universal receive FDA 510(k) clearance?

MRI Universal received FDA 510(k) clearance on 2024-07-12, under 510(k) number K240651.

Who is the listed applicant for MRI Universal?

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 MRI Universal?

The FDA product code for MRI Universal is JEY.

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Fonte oficial

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