FDA 510(k)

Clickfine Pen Needle, Penfine Classic Pen Needle

Número K: K171984 · 2017-10-11

Data da decisão2017-10-11

Código do produtoFMI

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Clickfine Pen Needle, Penfine Classic Pen Needle is the device name listed in this FDA 510(k) record. The listed applicant is Ypsomed AG. It received FDA 510(k) clearance on 2017-10-11 under 510(k) number K171984. 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 Clickfine Pen Needle, Penfine Classic Pen Needle?

Clickfine Pen Needle, Penfine Classic Pen Needle is a medical device that received FDA 510(k) clearance on 2017-10-11. The listed applicant is Ypsomed AG. The 510(k) number is K171984.

When did Clickfine Pen Needle, Penfine Classic Pen Needle receive FDA 510(k) clearance?

Clickfine Pen Needle, Penfine Classic Pen Needle received FDA 510(k) clearance on 2017-10-11, under 510(k) number K171984.

Who is the listed applicant for Clickfine Pen Needle, Penfine Classic Pen Needle?

The FDA 510(k) record lists Ypsomed AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Clickfine Pen Needle, Penfine Classic Pen Needle?

The FDA product code for Clickfine Pen Needle, Penfine Classic Pen Needle is FMI.

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Dispositivos Relacionados (Código: FMI)

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.

Fonte oficial

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