FDA 510(k)

FreeStyle Libre 2系统，FreeStyle Libre 3系统

K号: K223537 · 2023-02-21

决定日期2023-02-21

产品代码QLG

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决定实质等同

器械摘要

FreeStyle Libre 2 System, FreeStyle Libre 3 System 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 2023-02-21 under 510(k) number K223537. 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 System, FreeStyle Libre 3 System?

FreeStyle Libre 2 System, FreeStyle Libre 3 System is a medical device that received FDA 510(k) clearance on 2023-02-21. The listed applicant is Abbott Diabetes Care, Inc.. The 510(k) number is K223537.

When did FreeStyle Libre 2 System, FreeStyle Libre 3 System receive FDA 510(k) clearance?

FreeStyle Libre 2 System, FreeStyle Libre 3 System received FDA 510(k) clearance on 2023-02-21, under 510(k) number K223537.

Who is the listed applicant for FreeStyle Libre 2 System, FreeStyle Libre 3 System?

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 System, FreeStyle Libre 3 System?

The FDA product code for FreeStyle Libre 2 System, FreeStyle Libre 3 System is QLG.

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 K213996FreeStyle Libre 3连续血糖监测系统 K212132FreeStyle Libre 3连续血糖监测系统 K210943FreeStyle Libre 2闪式血糖监测系统（含FreeStyle Libre 2应用程序）

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.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.K210943FreeStyle Libre 2闪式血糖监测系统（含FreeStyle Libre 2应用程序）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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