Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System
K-Number: K200876 · 2020-12-04
ApplicantDexcom, Inc.
Decision Date2020-12-04
Product CodeQBJ
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System is a medical device manufactured by Dexcom, Inc.. It received FDA 510(k) clearance on 2020-12-04 under approval number K200876. The device is classified under product code QBJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System?
Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2020-12-04. It is manufactured by Dexcom, Inc.. The 510(k) number is K200876.
When was Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System approved by the FDA?
Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System received FDA 510(k) clearance on 2020-12-04, under approval number K200876.
What company makes Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System?
Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System is manufactured by Dexcom, Inc..
What is the FDA product code for Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System?
The FDA product code for Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System is QBJ.
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Other Devices by Dexcom, Inc.
K182405Dexcom Pro Q Continuous Glucose Monitoring System
K182041Dexcom G6 Glucose Program Continuous Glucose Monitoring System
DEN170088Dexcom G6 Continuous Glucose Monitoring System
K192787Dexcom G6 Glucose Program Continuous Glucose Monitoring (GCM) System
K191833Dexcom G6 Pro Continuous Glucose Monitoring System
K191450Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System and Dexcom Pro Q Continuous Glucose Monitoring System
Related Devices (Code: QBJ)
DEN170088Dexcom G6 Continuous Glucose Monitoring SystemDexcom, Inc.
K191450Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System and Dexcom Pro Q Continuous Glucose Monitoring SystemDexcom, Inc.
K183206Dexcom G6 Continuous Glucose Monitoring SystemDexcom, Inc.
K201328Dexcom G6 Continuous Glucose Monitoring (CGM) SystemDexcom, Inc.
K213919Dexcom G7 Continuous Glucose Monitoring SystemDexcom, Inc.
K221259Dexcom G6 Continuous Glucose Monitoring (CGM) System, Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System, Dexcom G6 Professional Continuous Glucose Monitoring (CGM) SystemDexcom, Inc.
Official Source
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