FDA 510(k)

Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type)

Numéro K : K202319 · 2021-11-12

DemandeurTianjin Huahong Technology Co., Ltd.

Date de décision2021-11-12

Code produitFMI

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type) is the device name listed in this FDA 510(k) record. The listed applicant is Tianjin Huahong Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-11-12 under 510(k) number K202319. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type)?

Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type) is a medical device that received FDA 510(k) clearance on 2021-11-12. The listed applicant is Tianjin Huahong Technology Co., Ltd.. The 510(k) number is K202319.

When did Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type) receive FDA 510(k) clearance?

Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type) received FDA 510(k) clearance on 2021-11-12, under 510(k) number K202319.

Who is the listed applicant for Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type)?

The FDA 510(k) record lists Tianjin Huahong Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type)?

The FDA product code for Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type) is FMI.

Essais cliniques associés

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Dispositifs connexes (Code : 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.

Source officielle

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