FDA 510(k)

Disposable Medical Safety Hypodermic Needle

K-번호: K220603 · 2022-08-23

결정일2022-08-23

제품 코드FMI

자문 위원회HO

결정Substantially Equivalent

기기 요약

Disposable Medical Safety Hypodermic Needle is the device name listed in this FDA 510(k) record. The listed applicant is Hantech Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2022-08-23 under 510(k) number K220603. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Disposable Medical Safety Hypodermic Needle?

Disposable Medical Safety Hypodermic Needle is a medical device that received FDA 510(k) clearance on 2022-08-23. The listed applicant is Hantech Medical Device Co., Ltd.. The 510(k) number is K220603.

When did Disposable Medical Safety Hypodermic Needle receive FDA 510(k) clearance?

Disposable Medical Safety Hypodermic Needle received FDA 510(k) clearance on 2022-08-23, under 510(k) number K220603.

Who is the listed applicant for Disposable Medical Safety Hypodermic Needle?

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

What is the FDA product code for Disposable Medical Safety Hypodermic Needle?

The FDA product code for Disposable Medical Safety Hypodermic Needle is FMI.

Hantech Medical Device Co., Ltd.를 신청인으로 등재한 기타 기록

K231363Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010)K222739Disposable Insulin Pen Needle K222672Disposable Insulin Syringe K221038Disposable Medical Masks

관련 기기 (코드: 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.

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