NovoFine® Plus — 510(k) de la FDA K231255

Resumen del dispositivo

NovoFine® Plus 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 2023-08-25 under 510(k) number K231255. 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® Plus?

NovoFine® Plus is a medical device that received FDA 510(k) clearance on 2023-08-25. The listed applicant is Novo Nordisk, Inc.. The 510(k) number is K231255.

When did NovoFine® Plus receive FDA 510(k) clearance?

NovoFine® Plus received FDA 510(k) clearance on 2023-08-25, under 510(k) number K231255.

Who is the listed applicant for NovoFine® Plus?

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® Plus?

The FDA product code for NovoFine® Plus is FMI.

Ensayos clínicos relacionados

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

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Dispositivos relacionados (Código: FMI)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K261266MOWANA™ Auto DuoPENTAMASTER MEDIQ SDN BHD K261719Promisemed X-Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.K262427Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII)Hh Global Technology, Inc.K260933Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T)Hangzhou Qiantang Longyue Biotechnology Co., Ltd.K261829Profoject™ Dual-Safety Pen NeedlesCMT Health PTE., Ltd.K260739Profoject™ Pen Needles (Model A; Model B)CMT Health PTE., Ltd.

Fuente oficial

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