FDA 510(k)

Light-Guide Cables

Número K: K223183 · 2023-01-13

Data da decisão2023-01-13

Código do produtoHBI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Light-Guide Cables is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Winter & Ibe GmbH. It received FDA 510(k) clearance on 2023-01-13 under 510(k) number K223183. The device is classified under product code HBI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Light-Guide Cables?

Light-Guide Cables is a medical device that received FDA 510(k) clearance on 2023-01-13. The listed applicant is Olympus Winter & Ibe GmbH. The 510(k) number is K223183.

When did Light-Guide Cables receive FDA 510(k) clearance?

Light-Guide Cables received FDA 510(k) clearance on 2023-01-13, under 510(k) number K223183.

Who is the listed applicant for Light-Guide Cables?

The FDA 510(k) record lists Olympus Winter & Ibe GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Light-Guide Cables?

The FDA product code for Light-Guide Cables is HBI.

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Fonte oficial

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