FDA 510(k)

NovoPen Echo

K号: K162602 · 2016-10-18

决定日期2016-10-18

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

NovoPen Echo is the device name listed in this FDA 510(k) record. The listed applicant is Novo Nordisk, Inc.. It received FDA 510(k) clearance on 2016-10-18 under 510(k) number K162602. 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 NovoPen Echo?

NovoPen Echo is a medical device that received FDA 510(k) clearance on 2016-10-18. The listed applicant is Novo Nordisk, Inc.. The 510(k) number is K162602.

When did NovoPen Echo receive FDA 510(k) clearance?

NovoPen Echo received FDA 510(k) clearance on 2016-10-18, under 510(k) number K162602.

Who is the listed applicant for NovoPen Echo?

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

What is the FDA product code for NovoPen Echo?

The FDA product code for NovoPen Echo is FMF.

列明Novo Nordisk, 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。

K231255NovoFine® Plus K210258NovoFine K202005NovoFine Plus 32G 提 x 4 mm K182387NovoPen Echo Dial-A-Dose 胰岛素输送装置（注射笔）K173479NovoFine 32G 提 (0.23/0.25) x 6 mm ETW (超薄壁)

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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