FDA 510(k)

Safety Insulin Pen Needles

K-Nummer: K213183 · 2022-10-14

AntragstellerZhejiang Kindly Medical Devices Co., Ltd.

Entscheidungsdatum2022-10-14

ProduktcodeFMI

BeratungsausschussHO

EntscheidungSubstantially Equivalent

Produktübersicht

Safety Insulin Pen Needles is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Kindly Medical Devices Co., Ltd.. It received FDA 510(k) clearance on 2022-10-14 under 510(k) number K213183. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Safety Insulin Pen Needles?

Safety Insulin Pen Needles is a medical device that received FDA 510(k) clearance on 2022-10-14. The listed applicant is Zhejiang Kindly Medical Devices Co., Ltd.. The 510(k) number is K213183.

When did Safety Insulin Pen Needles receive FDA 510(k) clearance?

Safety Insulin Pen Needles received FDA 510(k) clearance on 2022-10-14, under 510(k) number K213183.

Who is the listed applicant for Safety Insulin Pen Needles?

The FDA 510(k) record lists Zhejiang Kindly Medical Devices Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Safety Insulin Pen Needles?

The FDA product code for Safety Insulin Pen Needles is FMI.

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Weitere Einträge mit Zhejiang Kindly Medical Devices Co., Ltd. als Antragsteller

K223334Sterile Hypodermic Needles for Single Use K181069Disposable Insulin Pen Needle K172763Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle with Holder, Safety Blood Collecting Needle with Holder, Blood Collecting Set, Safety Blood Collecting Set, Blood Collecting Set with Holder, Safety Blood Collecting Set with Holder K171518Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia Needles

Verwandte Geräte (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.

Offizielle Quelle

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