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FDA 510(k)

DropSafe 安全笔式注射针

K号: K211716 · 2022-01-07

申请人Htl Strefa SA
决定日期2022-01-07
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 Needles is the device name listed in this FDA 510(k) record. The listed applicant is Htl Strefa SA. It received FDA 510(k) clearance on 2022-01-07 under 510(k) number K211716. 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 Needles?

DropSafe Safety Pen Needles is a medical device that received FDA 510(k) clearance on 2022-01-07. The listed applicant is Htl Strefa SA. The 510(k) number is K211716.

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

DropSafe Safety Pen Needles received FDA 510(k) clearance on 2022-01-07, under 510(k) number K211716.

Who is the listed applicant for DropSafe Safety Pen Needles?

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

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

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

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

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 BHDK261719Promisemed 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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