FDA 510(k)

EZ-Inject Single use Needle

K-번호: K192222 · 2020-05-12

결정일2020-05-12

제품 코드FMI

자문 위원회HO

결정Substantially Equivalent

기기 요약

EZ-Inject Single use Needle is the device name listed in this FDA 510(k) record. The listed applicant is Poonglim Pharmatech, Inc.. It received FDA 510(k) clearance on 2020-05-12 under 510(k) number K192222. 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 EZ-Inject Single use Needle?

EZ-Inject Single use Needle is a medical device that received FDA 510(k) clearance on 2020-05-12. The listed applicant is Poonglim Pharmatech, Inc.. The 510(k) number is K192222.

When did EZ-Inject Single use Needle receive FDA 510(k) clearance?

EZ-Inject Single use Needle received FDA 510(k) clearance on 2020-05-12, under 510(k) number K192222.

Who is the listed applicant for EZ-Inject Single use Needle?

The FDA 510(k) record lists Poonglim Pharmatech, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EZ-Inject Single use Needle?

The FDA product code for EZ-Inject Single use Needle is FMI.

Poonglim Pharmatech, Inc.를 신청인으로 등재한 기타 기록

K241190PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe; PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe K221860PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe, PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe K210443PLPT LDV (Low Dead Volume) Sterile Syringe K210444EZ-Injec LDV Sterile Safety Needle K172483Kopac Sterile Needle

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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