FDA 510(k)

Pre-Sure

Número K: K230044 · 2023-05-26

Data da decisão2023-05-26

Código do produtoLLZ

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Pre-Sure is the device name listed in this FDA 510(k) record. The listed applicant is Lazarus 3D. It received FDA 510(k) clearance on 2023-05-26 under 510(k) number K230044. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Pre-Sure?

Pre-Sure is a medical device that received FDA 510(k) clearance on 2023-05-26. The listed applicant is Lazarus 3D. The 510(k) number is K230044.

When did Pre-Sure receive FDA 510(k) clearance?

Pre-Sure received FDA 510(k) clearance on 2023-05-26, under 510(k) number K230044.

Who is the listed applicant for Pre-Sure?

The FDA 510(k) record lists Lazarus 3D as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pre-Sure?

The FDA product code for Pre-Sure is LLZ.

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Fonte oficial

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