FDA 510(k)

Insulia糖尿病管理伴侣

K号: K202596 · 2021-06-04

决定日期2021-06-04

产品代码NDC

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决定实质等同

器械摘要

Insulia Diabetes Management Companion is the device name listed in this FDA 510(k) record. The listed applicant is Voluntis Sa.. It received FDA 510(k) clearance on 2021-06-04 under 510(k) number K202596. The device is classified under product code NDC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Insulia Diabetes Management Companion?

Insulia Diabetes Management Companion is a medical device that received FDA 510(k) clearance on 2021-06-04. The listed applicant is Voluntis Sa.. The 510(k) number is K202596.

When did Insulia Diabetes Management Companion receive FDA 510(k) clearance?

Insulia Diabetes Management Companion received FDA 510(k) clearance on 2021-06-04, under 510(k) number K202596.

Who is the listed applicant for Insulia Diabetes Management Companion?

The FDA 510(k) record lists Voluntis Sa. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Insulia Diabetes Management Companion?

The FDA product code for Insulia Diabetes Management Companion is NDC.

列明Voluntis Sa.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。

K232451Insulia剂量伴侣 K172177Insulia糖尿病管理伴侣 K170669Insulia糖尿病管理伴侣 K161433Insulia糖尿病管理伴侣

官方来源

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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。