FDA 510(k)

BlueStar CGM 胰岛素剂量计算器

K号: K222888 · 2023-08-11

决定日期2023-08-11

产品代码QRX

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决定实质等同

器械摘要

BlueStar CGM insulin dose calculator is the device name listed in this FDA 510(k) record. The listed applicant is Welldoc, Inc.. It received FDA 510(k) clearance on 2023-08-11 under 510(k) number K222888. The device is classified under product code QRX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the BlueStar CGM insulin dose calculator?

BlueStar CGM insulin dose calculator is a medical device that received FDA 510(k) clearance on 2023-08-11. The listed applicant is Welldoc, Inc.. The 510(k) number is K222888.

When did BlueStar CGM insulin dose calculator receive FDA 510(k) clearance?

BlueStar CGM insulin dose calculator received FDA 510(k) clearance on 2023-08-11, under 510(k) number K222888.

Who is the listed applicant for BlueStar CGM insulin dose calculator?

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

What is the FDA product code for BlueStar CGM insulin dose calculator?

The FDA product code for BlueStar CGM insulin dose calculator is QRX.

列明Welldoc, 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。

K230813BlueStar 和 BlueStar Rx K203434BlueStar Rx K193654BlueStar Rx K190013WellDoc 蓝星 K162532WellDoc蓝星，WellDoc蓝星Rx K162225WellDoc BlueStar（WellDoc糖尿病管理系统及糖尿病管理-Rx系统）

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官方来源

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