FDA 510(k)

一次性使用的安全血液采集装置

K号: K170276 · 2017-12-11

决定日期2017-12-11

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

Safety Blood Collection Device for Single Use is the device name listed in this FDA 510(k) record. The listed applicant is Gemtier Medical (Shanghai), Inc.. It received FDA 510(k) clearance on 2017-12-11 under 510(k) number K170276. 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 Blood Collection Device for Single Use?

Safety Blood Collection Device for Single Use is a medical device that received FDA 510(k) clearance on 2017-12-11. The listed applicant is Gemtier Medical (Shanghai), Inc.. The 510(k) number is K170276.

When did Safety Blood Collection Device for Single Use receive FDA 510(k) clearance?

Safety Blood Collection Device for Single Use received FDA 510(k) clearance on 2017-12-11, under 510(k) number K170276.

Who is the listed applicant for Safety Blood Collection Device for Single Use?

The FDA 510(k) record lists Gemtier Medical (Shanghai), Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Safety Blood Collection Device for Single Use?

The FDA product code for Safety Blood Collection Device for Single Use is FMI.

列明Gemtier Medical (Shanghai), Inc.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。

K212652无菌一次性使用固定安全针注射器 K202493医疗口罩 K202331医疗口罩 K192679无菌一次性使用安全针注射器，无菌一次性使用注射器，无菌一次性使用安全针

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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