FDA 510(k)

Dexcom 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

K号: K253737 · 2026-02-03

决定日期2026-02-03

产品代码QBJ

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

Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System is the device name listed in this FDA 510(k) record. The listed applicant is Dexcom, Inc.. It received FDA 510(k) clearance on 2026-02-03 under 510(k) number K253737. 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 Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System?

Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System is a medical device that received FDA 510(k) clearance on 2026-02-03. The listed applicant is Dexcom, Inc.. The 510(k) number is K253737.

When did Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System receive FDA 510(k) clearance?

Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System received FDA 510(k) clearance on 2026-02-03, under 510(k) number K253737.

Who is the listed applicant for Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System?

FDA 510(k)记录中列出Dexcom，Inc.为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System?

The FDA product code for Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System is QBJ.

列明Dexcom, 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。

K262472Stelo葡萄糖生物传感器系统 K260935Stelo葡萄糖生物传感器系统 K261402Dexcom G7 连续葡萄糖监测系统；Dexcom G7 15天连续葡萄糖监测系统 K261359Stelo葡萄糖生物传感器系统 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 K252818Dexcom Smart Basal

查看所有 25 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.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.K234133Dexcom G7 连续葡萄糖监测系统Dexcom, Inc.

官方来源

在 FDA 数据库中查看 →

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。