FDA 510(k)

DropSafe 安全笔式注射针

K号: K170988 · 2017-12-12

决定日期2017-12-12

产品代码FMI

咨询委员会医疗设备监管文本翻译如下： HO 请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。

决定实质等同

器械摘要

DropSafe Safety Pen Needle is the device name listed in this FDA 510(k) record. The listed applicant is Htl-Strefa S.A. It received FDA 510(k) clearance on 2017-12-12 under 510(k) number K170988. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the DropSafe Safety Pen Needle?

DropSafe Safety Pen Needle is a medical device that received FDA 510(k) clearance on 2017-12-12. The listed applicant is Htl-Strefa S.A. The 510(k) number is K170988.

When did DropSafe Safety Pen Needle receive FDA 510(k) clearance?

DropSafe Safety Pen Needle received FDA 510(k) clearance on 2017-12-12, under 510(k) number K170988.

Who is the listed applicant for DropSafe Safety Pen Needle?

The FDA 510(k) record lists Htl-Strefa S.A as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DropSafe Safety Pen Needle?

The FDA product code for DropSafe Safety Pen Needle is FMI.

列明Htl-Strefa S.A为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K250016droplet®个人采血针 K220643DropSafe Acti-Lance 安全注射针；滴液 ACTI-LANCE 安全注射针，DropSafe Medlance Plus 安全注射针；滴液 MEDLANCE PLUS 安全注射针，DropSafe ergoLance 安全注射针，DropSafe Prolance 安全注射针，DropSafe Medisafe Solo 安全注射针；DropSafe Haemolance Plus 安全注射针 K202340Droplet Pen Needle 30G & 33G K192082Droplet Pen Needle 34G K171982DROPLET 笔式注射针

相关器械（代码：FMI）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K261266MOWANA™ 自动双联PENTAMASTER MEDIQ SDN BHD K261719Promisemed X 安全笔式针头Promisemed Hangzhou Meditech Co., Ltd.K262427注射针（普通型I类，安全型IIA，安全型IIB，安全型IIIA，安全型IIIB，安全型IV，安全型V，普通型VIA，普通型VIB，普通型VIC，安全型VII，普通型IB，安全型VIII，安全型IX，安全型X，普通型XI，安全型XII）Hh Global Technology, Inc.K260933安全无菌皮下注射针（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™ 双重安全笔式针头CMT Health PTE., Ltd.K260739Profoject™ 注射针（型号A；型号B）CMT Health PTE., Ltd.

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