FDA 510(k)

MicroDose Injector

Número K: K203264 · 2021-04-26

Data da decisão2021-04-26

Código do produtoFMF

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

MicroDose Injector is the device name listed in this FDA 510(k) record. The listed applicant is Medone Surgical, Inc.. It received FDA 510(k) clearance on 2021-04-26 under 510(k) number K203264. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the MicroDose Injector?

MicroDose Injector is a medical device that received FDA 510(k) clearance on 2021-04-26. The listed applicant is Medone Surgical, Inc.. The 510(k) number is K203264.

When did MicroDose Injector receive FDA 510(k) clearance?

MicroDose Injector received FDA 510(k) clearance on 2021-04-26, under 510(k) number K203264.

Who is the listed applicant for MicroDose Injector?

The FDA 510(k) record lists Medone Surgical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MicroDose Injector?

The FDA product code for MicroDose Injector is FMF.

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Fonte oficial

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