FDA 510(k)

neo315

Número K: K231133 · 2024-07-22

Data da decisão2024-07-22

Código do produtoLNH

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

neo315 is the device name listed in this FDA 510(k) record. The listed applicant is Neoscan Solution GmbH. It received FDA 510(k) clearance on 2024-07-22 under 510(k) number K231133. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the neo315?

neo315 is a medical device that received FDA 510(k) clearance on 2024-07-22. The listed applicant is Neoscan Solution GmbH. The 510(k) number is K231133.

When did neo315 receive FDA 510(k) clearance?

neo315 received FDA 510(k) clearance on 2024-07-22, under 510(k) number K231133.

Who is the listed applicant for neo315?

The FDA 510(k) record lists Neoscan Solution GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for neo315?

The FDA product code for neo315 is LNH.

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