FDA 510(k)

维斯科医疗NRFit注射器

K号: K170218 · 2017-02-24

决定日期2017-02-24

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

Vesco Medical NRFit Tip Syringes is the device name listed in this FDA 510(k) record. The listed applicant is Vesco Medical, LLC. It received FDA 510(k) clearance on 2017-02-24 under 510(k) number K170218. 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 Vesco Medical NRFit Tip Syringes?

Vesco Medical NRFit Tip Syringes is a medical device that received FDA 510(k) clearance on 2017-02-24. The listed applicant is Vesco Medical, LLC. The 510(k) number is K170218.

When did Vesco Medical NRFit Tip Syringes receive FDA 510(k) clearance?

Vesco Medical NRFit Tip Syringes received FDA 510(k) clearance on 2017-02-24, under 510(k) number K170218.

Who is the listed applicant for Vesco Medical NRFit Tip Syringes?

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

What is the FDA product code for Vesco Medical NRFit Tip Syringes?

The FDA product code for Vesco Medical NRFit Tip Syringes is FMF.

列明Vesco Medical, LLC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。

K232205Vesco Q™ 肠内营养泵；Vesco Q™ 500mL 注射袋喂食套装；Vesco Q™ 1000mL 注射袋喂食套装；Vesco Q™ 40mm 螺纹盖喂食套装；Vesco Q™ ENPlus 喂食套装 K192991维斯科医疗延长喂养套装 K170162维斯科医疗鼻肠管

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

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