Clickfine 针笔，Penfine 经典针笔
K号: K171984 · 2017-10-11
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申请人Ypsomed AG
决定日期2017-10-11
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
Clickfine Pen Needle, Penfine Classic Pen Needle is the device name listed in this FDA 510(k) record. The listed applicant is Ypsomed AG. It received FDA 510(k) clearance on 2017-10-11 under 510(k) number K171984. 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 Clickfine Pen Needle, Penfine Classic Pen Needle?
Clickfine Pen Needle, Penfine Classic Pen Needle is a medical device that received FDA 510(k) clearance on 2017-10-11. The listed applicant is Ypsomed AG. The 510(k) number is K171984.
When did Clickfine Pen Needle, Penfine Classic Pen Needle receive FDA 510(k) clearance?
Clickfine Pen Needle, Penfine Classic Pen Needle received FDA 510(k) clearance on 2017-10-11, under 510(k) number K171984.
Who is the listed applicant for Clickfine Pen Needle, Penfine Classic Pen Needle?
The FDA 510(k) record lists Ypsomed AG as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Clickfine Pen Needle, Penfine Classic Pen Needle?
The FDA product code for Clickfine Pen Needle, Penfine Classic Pen Needle is FMI.
相关临床试验
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列明Ypsomed AG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。
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.
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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