FDA 510(k)

MEDOJECT fine Pen Needles

Número K: K220614 · 2022-06-15

Data da decisão2022-06-15

Código do produtoFMI

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

MEDOJECT fine Pen Needles is the device name listed in this FDA 510(k) record. The listed applicant is Chirana T. Injecta. It received FDA 510(k) clearance on 2022-06-15 under 510(k) number K220614. 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 MEDOJECT fine Pen Needles?

MEDOJECT fine Pen Needles is a medical device that received FDA 510(k) clearance on 2022-06-15. The listed applicant is Chirana T. Injecta. The 510(k) number is K220614.

When did MEDOJECT fine Pen Needles receive FDA 510(k) clearance?

MEDOJECT fine Pen Needles received FDA 510(k) clearance on 2022-06-15, under 510(k) number K220614.

Who is the listed applicant for MEDOJECT fine Pen Needles?

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

What is the FDA product code for MEDOJECT fine Pen Needles?

The FDA product code for MEDOJECT fine Pen Needles is FMI.

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Outros registros que listam Chirana T. Injecta como candidato(a)

K242434Insulin Syringes K201044CHIRANA Insulin Syringes K201009CHIRAVAC Blood Collection Needles

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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