FDA 510(k)

FreeStyle Libre 3连续血糖监测系统；FreeStyle Libre 2闪式血糖监测系统

K号: K223435 · 2023-04-13

决定日期2023-04-13

产品代码QBJ

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决定实质等同

器械摘要

FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring 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 2023-04-13 under 510(k) number K223435. The device is classified under product code QBJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System?

FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2023-04-13. The listed applicant is Abbott Diabetes Care, Inc.. The 510(k) number is K223435.

When did FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System receive FDA 510(k) clearance?

FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System received FDA 510(k) clearance on 2023-04-13, under 510(k) number K223435.

Who is the listed applicant for FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring 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 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System?

The FDA product code for FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System is QBJ.

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 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 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：QBJ）

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。

K261402Dexcom G7 连续葡萄糖监测系统；Dexcom G7 15天连续葡萄糖监测系统Dexcom, Inc.K253737Dexcom G7 连续葡萄糖监测（CGM）系统；Dexcom G7 15天连续葡萄糖监测（CGM）系统Dexcom, Inc.K253710Dexcom G7 连续葡萄糖监测（CGM）系统，Dexcom G7 15天连续葡萄糖监测（CGM）系统Dexcom, Inc.K243214Dexcom G7 15天连续葡萄糖监测系统Dexcom, Inc.K233537FreeStyle Libre 3连续血糖监测系统；FreeStyle Libre 2闪式血糖监测系统Abbott Diabetes Care, Inc.K240902Dexcom G7 连续葡萄糖监测系统Dexcom, Inc.

官方来源

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