FDA 510(k)

EpiFaith 注射器（Luer Slip），EpiFaith 注射器（NRFit）

K号: K182268 · 2019-04-05

决定日期2019-04-05

产品代码FMF

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

EpiFaith Syringe (Luer Slip) , EpiFaith Syringe (NRFit) is the device name listed in this FDA 510(k) record. The listed applicant is Flat Medical Co., Ltd.. It received FDA 510(k) clearance on 2019-04-05 under 510(k) number K182268. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the EpiFaith Syringe (Luer Slip) , EpiFaith Syringe (NRFit)?

EpiFaith Syringe (Luer Slip) , EpiFaith Syringe (NRFit) is a medical device that received FDA 510(k) clearance on 2019-04-05. The listed applicant is Flat Medical Co., Ltd.. The 510(k) number is K182268.

When did EpiFaith Syringe (Luer Slip) , EpiFaith Syringe (NRFit) receive FDA 510(k) clearance?

EpiFaith Syringe (Luer Slip) , EpiFaith Syringe (NRFit) received FDA 510(k) clearance on 2019-04-05, under 510(k) number K182268.

Who is the listed applicant for EpiFaith Syringe (Luer Slip) , EpiFaith Syringe (NRFit)?

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

What is the FDA product code for EpiFaith Syringe (Luer Slip) , EpiFaith Syringe (NRFit)?

The FDA product code for EpiFaith Syringe (Luer Slip) , EpiFaith Syringe (NRFit) is FMF.

列明Flat Medical 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。

K212615EpiFaith CV K192421EpiFaith 注射器

相关器械（代码：FMF）

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。

K262581GraftGun® 全能移植物输送系统（GDS®）SurGenTec, LLC K252184SOL-M可更换针盘式卢埃尔锁注射器Sol-Millennium Medical, Inc.K253747一次性笔式注射器（KXYC-03C02，KXYC-03A03）Jiangsu Enjosim Medical Technology Co., Ltd.K260208Ultra-Fine™ 安全胰岛素注射器embecta Medical II, LLC K253110Sol-Glide安全针；带注射器的Sol-Glide安全针。Sol-Millennium Medical, Inc.K260514Profoject™ 安全针；Profoject™ 带安全针的注射器；Profoject™ 低死腔注射器带安全针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。