FDA 510(k)

Tempo 智能按钮

K号: K212217 · 2022-09-16

决定日期2022-09-16

产品代码QOG

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

Tempo Smart Button is the device name listed in this FDA 510(k) record. The listed applicant is Eli Lilly and Company. It received FDA 510(k) clearance on 2022-09-16 under 510(k) number K212217. The device is classified under product code QOG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Tempo Smart Button?

Tempo Smart Button is a medical device that received FDA 510(k) clearance on 2022-09-16. The listed applicant is Eli Lilly and Company. The 510(k) number is K212217.

When did Tempo Smart Button receive FDA 510(k) clearance?

Tempo Smart Button received FDA 510(k) clearance on 2022-09-16, under 510(k) number K212217.

Who is the listed applicant for Tempo Smart Button?

The FDA 510(k) record lists Eli Lilly and Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tempo Smart Button?

The FDA product code for Tempo Smart Button is QOG.

列明Eli Lilly and Company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。

K160949Go Dose System

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。