FDA 510(k)

NovoFine 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall)

N.º K: K173479 · 2018-01-17

Fecha de decisión2018-01-17

Código de productoFMI

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

NovoFine 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall) 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 2018-01-17 under 510(k) number K173479. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the NovoFine 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall)?

NovoFine 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall) is a medical device that received FDA 510(k) clearance on 2018-01-17. The listed applicant is Novo Nordisk, Inc.. The 510(k) number is K173479.

When did NovoFine 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall) receive FDA 510(k) clearance?

NovoFine 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall) received FDA 510(k) clearance on 2018-01-17, under 510(k) number K173479.

Who is the listed applicant for NovoFine 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall)?

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 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall)?

The FDA product code for NovoFine 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall) is FMI.

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Otros registros que enlistan a Novo Nordisk, Inc. como solicitante

K231255NovoFine® Plus K210258NovoFine K202005NovoFine Plus 32G Tip x 4 mm K182387NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)K162602NovoPen Echo

Dispositivos relacionados (Código: FMI)

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Fuente oficial

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