FDA 510(k)

VACUETTE SAFELINK Holder with male luer lock

K-번호: K180545 · 2018-05-21

결정일2018-05-21

제품 코드FMI

자문 위원회HO

결정Substantially Equivalent

기기 요약

VACUETTE SAFELINK Holder with male luer lock is the device name listed in this FDA 510(k) record. The listed applicant is Greiner Bio-One Na, Inc.. It received FDA 510(k) clearance on 2018-05-21 under 510(k) number K180545. 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 VACUETTE SAFELINK Holder with male luer lock?

VACUETTE SAFELINK Holder with male luer lock is a medical device that received FDA 510(k) clearance on 2018-05-21. The listed applicant is Greiner Bio-One Na, Inc.. The 510(k) number is K180545.

When did VACUETTE SAFELINK Holder with male luer lock receive FDA 510(k) clearance?

VACUETTE SAFELINK Holder with male luer lock received FDA 510(k) clearance on 2018-05-21, under 510(k) number K180545.

Who is the listed applicant for VACUETTE SAFELINK Holder with male luer lock?

The FDA 510(k) record lists Greiner Bio-One Na, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VACUETTE SAFELINK Holder with male luer lock?

The FDA product code for VACUETTE SAFELINK Holder with male luer lock is FMI.

Greiner Bio-One Na, Inc.를 신청인으로 등재한 기타 기록

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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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