FDA 510(k)

ELLAVI UBT

Número K: K230849 · 2023-11-13

RequerenteSinapi Biomedical (Pty) , Ltd.

Data da decisão2023-11-13

Código do produtoOQY

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

ELLAVI UBT is the device name listed in this FDA 510(k) record. The listed applicant is Sinapi Biomedical (Pty) , Ltd.. It received FDA 510(k) clearance on 2023-11-13 under 510(k) number K230849. The device is classified under product code OQY. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ELLAVI UBT?

ELLAVI UBT is a medical device that received FDA 510(k) clearance on 2023-11-13. The listed applicant is Sinapi Biomedical (Pty) , Ltd.. The 510(k) number is K230849.

When did ELLAVI UBT receive FDA 510(k) clearance?

ELLAVI UBT received FDA 510(k) clearance on 2023-11-13, under 510(k) number K230849.

Who is the listed applicant for ELLAVI UBT?

The FDA 510(k) record lists Sinapi Biomedical (Pty) , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELLAVI UBT?

The FDA product code for ELLAVI UBT is OQY.

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