FDA 510(k)

Bella-mu

Número K: K190962 · 2020-02-03

Data da decisão2020-02-03

Código do produtoFMI

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Bella-mu is the device name listed in this FDA 510(k) record. The listed applicant is U-Needle B.V.. It received FDA 510(k) clearance on 2020-02-03 under 510(k) number K190962. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Bella-mu?

Bella-mu is a medical device that received FDA 510(k) clearance on 2020-02-03. The listed applicant is U-Needle B.V.. The 510(k) number is K190962.

When did Bella-mu receive FDA 510(k) clearance?

Bella-mu received FDA 510(k) clearance on 2020-02-03, under 510(k) number K190962.

Who is the listed applicant for Bella-mu?

The FDA 510(k) record lists U-Needle B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bella-mu?

The FDA product code for Bella-mu is FMI.

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