FDA 510(k)

NovoPen Echo Dial-A-Dose 胰岛素输送装置（注射笔）

K号: K182387 · 2018-12-17

决定日期2018-12-17

产品代码FMF

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决定实质等同

器械摘要

NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector) 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 2018-12-17 under 510(k) number K182387. 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 Dial-A-Dose Insulin Delivery Device (Pen Injector)?

NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector) is a medical device that received FDA 510(k) clearance on 2018-12-17. The listed applicant is Novo Nordisk, Inc.. The 510(k) number is K182387.

When did NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector) receive FDA 510(k) clearance?

NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector) received FDA 510(k) clearance on 2018-12-17, under 510(k) number K182387.

Who is the listed applicant for NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)?

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 Dial-A-Dose Insulin Delivery Device (Pen Injector)?

The FDA product code for NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector) 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 K173479NovoFine 32G 提 (0.23/0.25) x 6 mm ETW (超薄壁)K162602NovoPen Echo

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。

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官方来源

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