FDA 510(k)

UniCam Evo Software

Número K: K230393 · 2023-04-13

RequerenteInter Medical Medizintechnik GmbH

Data da decisão2023-04-13

Código do produtoLLZ

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

UniCam Evo Software is the device name listed in this FDA 510(k) record. The listed applicant is Inter Medical Medizintechnik GmbH. It received FDA 510(k) clearance on 2023-04-13 under 510(k) number K230393. 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 UniCam Evo Software?

UniCam Evo Software is a medical device that received FDA 510(k) clearance on 2023-04-13. The listed applicant is Inter Medical Medizintechnik GmbH. The 510(k) number is K230393.

When did UniCam Evo Software receive FDA 510(k) clearance?

UniCam Evo Software received FDA 510(k) clearance on 2023-04-13, under 510(k) number K230393.

Who is the listed applicant for UniCam Evo Software?

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

What is the FDA product code for UniCam Evo Software?

The FDA product code for UniCam Evo Software is LLZ.

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