FDA 510(k)

Dexcom G6 葡萄糖程序连续葡萄糖监测（CGM）系统

K号: K193642 · 2020-01-29

决定日期2020-01-29

产品代码QDK

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决定实质等同

器械摘要

Dexcom G6 Glucose Program 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 2020-01-29 under 510(k) number K193642. The device is classified under product code QDK. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System?

Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System is a medical device that received FDA 510(k) clearance on 2020-01-29. The listed applicant is Dexcom, Inc.. The 510(k) number is K193642.

When did Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System receive FDA 510(k) clearance?

Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System received FDA 510(k) clearance on 2020-01-29, under 510(k) number K193642.

Who is the listed applicant for Dexcom G6 Glucose Program 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 G6 Glucose Program Continuous Glucose Monitoring (CGM) System?

The FDA product code for Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System is QDK.

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 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 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

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