FDA 510(k)

endo数字平台

K号: K232722 · 2023-10-03

决定日期2023-10-03

产品代码QCC

咨询委员会CH 请注意，您提供的文本“CH”不足以进行翻译。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。

决定实质等同

器械摘要

endo.digital Platform is the device name listed in this FDA 510(k) record. The listed applicant is DreaMed Diabetes, Ltd.. It received FDA 510(k) clearance on 2023-10-03 under 510(k) number K232722. The device is classified under product code QCC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the endo.digital Platform?

endo.digital Platform is a medical device that received FDA 510(k) clearance on 2023-10-03. The listed applicant is DreaMed Diabetes, Ltd.. The 510(k) number is K232722.

When did endo.digital Platform receive FDA 510(k) clearance?

endo.digital Platform received FDA 510(k) clearance on 2023-10-03, under 510(k) number K232722.

Who is the listed applicant for endo.digital Platform?

FDA 510(k)记录将DreaMed Diabetes, Ltd.列为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for endo.digital Platform?

The FDA product code for endo.digital Platform is QCC.

列明DreaMed Diabetes, 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。

K260062MODI系统 K210561Advisor Pro平台 K201476DreaMed Advisor Pro K191370DreaMed Advisor Pro

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。