FDA 510(k)

一次性安全笔式注射针，胰岛素笔针

K号: K212514 · 2022-04-29

决定日期2022-04-29

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

Safety Pen Needle for Single Use, Insulin Pen Needles is the device name listed in this FDA 510(k) record. The listed applicant is Berpu Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-04-29 under 510(k) number K212514. 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 Safety Pen Needle for Single Use, Insulin Pen Needles?

Safety Pen Needle for Single Use, Insulin Pen Needles is a medical device that received FDA 510(k) clearance on 2022-04-29. The listed applicant is Berpu Medical Technology Co., Ltd.. The 510(k) number is K212514.

When did Safety Pen Needle for Single Use, Insulin Pen Needles receive FDA 510(k) clearance?

Safety Pen Needle for Single Use, Insulin Pen Needles received FDA 510(k) clearance on 2022-04-29, under 510(k) number K212514.

Who is the listed applicant for Safety Pen Needle for Single Use, Insulin Pen Needles?

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

What is the FDA product code for Safety Pen Needle for Single Use, Insulin Pen Needles?

The FDA product code for Safety Pen Needle for Single Use, Insulin Pen Needles is FMI.

列明Berpu Medical Technology Co., Ltd.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。

K232165无菌一次性使用安全皮下注射针；无菌一次性使用皮下注射针-一次性注射针；无菌一次性使用安全皮下注射针-自封式注射针 K221045无针胰岛素注射器 K220061安全胰岛素注射器 K213158带永久连接针头的注射器 K213811一次性无菌皮下注射器 K181447一次性使用的安全胰岛素针

查看所有 9 个设备 →

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.

官方来源

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