FDA 510(k)

NovoFine

Número K: K210258 · 2021-06-23

Data da decisão2021-06-23

Código do produtoFMI

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

NovoFine is the device name listed in this FDA 510(k) record. The listed applicant is Novo Nordisk, Inc.. It received FDA 510(k) clearance on 2021-06-23 under 510(k) number K210258. 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 NovoFine?

NovoFine is a medical device that received FDA 510(k) clearance on 2021-06-23. The listed applicant is Novo Nordisk, Inc.. The 510(k) number is K210258.

When did NovoFine receive FDA 510(k) clearance?

NovoFine received FDA 510(k) clearance on 2021-06-23, under 510(k) number K210258.

Who is the listed applicant for NovoFine?

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

What is the FDA product code for NovoFine?

The FDA product code for NovoFine is FMI.

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Outros registros que listam Novo Nordisk, Inc. como candidato(a)

K231255NovoFine® Plus K202005NovoFine Plus 32G Tip x 4 mm K182387NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)K173479NovoFine 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall)K162602NovoPen Echo

Dispositivos Relacionados (Código: FMI)

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