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FDA 510(k)

FreeStyle Libre 2闪式血糖监测系统（含FreeStyle Libre 2应用程序）

K号: K210943 · 2021-11-22

申请人Abbott Diabetes Care, Inc.
决定日期2021-11-22
产品代码QLG
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

FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Diabetes Care, Inc.. It received FDA 510(k) clearance on 2021-11-22 under 510(k) number K210943. The device is classified under product code QLG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)?

FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) is a medical device that received FDA 510(k) clearance on 2021-11-22. The listed applicant is Abbott Diabetes Care, Inc.. The 510(k) number is K210943.

When did FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) receive FDA 510(k) clearance?

FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) received FDA 510(k) clearance on 2021-11-22, under 510(k) number K210943.

Who is the listed applicant for FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)?

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

What is the FDA product code for FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)?

The FDA product code for FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) is QLG.

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Abbott Diabetes Care, 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。

K233537FreeStyle Libre 3连续血糖监测系统；FreeStyle Libre 2闪式血糖监测系统K223435FreeStyle Libre 3连续血糖监测系统；FreeStyle Libre 2闪式血糖监测系统K222447FreeStyle Libre 2闪式血糖监测系统；Freestyle Libre 3连续血糖监测系统K223537FreeStyle Libre 2系统，FreeStyle Libre 3系统K213996FreeStyle Libre 3连续血糖监测系统K212132FreeStyle Libre 3连续血糖监测系统

查看所有 12 个设备 →

相关器械（代码：QLG）

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。

K222280Bigfoot Unity® 糖尿病管理系统Bigfoot Biomedical, Inc.K223537FreeStyle Libre 2系统，FreeStyle Libre 3系统Abbott Diabetes Care, Inc.K213996FreeStyle Libre 3连续血糖监测系统Abbott Diabetes Care, Inc.K212132FreeStyle Libre 3连续血糖监测系统Abbott Diabetes Care, Inc.K211102FreeStyle Libre 2闪式血糖监测系统Abbott Diabetes Care, Inc.K201761FreeStyle Libre 2闪式血糖监测系统（含FreeStyle Libre 2应用程序）Abbott Diabetes Care, Inc.

官方来源

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