Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System
K-Number: K203089 · 2021-08-17
ApplicantDexcom, Inc.
Decision Date2021-08-17
Product CodeQDK
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System is a medical device manufactured by Dexcom, Inc.. It received FDA 510(k) clearance on 2021-08-17 under approval number K203089. The device is classified under product code QDK. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
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 2021-08-17. It is manufactured by Dexcom, Inc.. The 510(k) number is K203089.
When was Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System approved by the FDA?
Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System received FDA 510(k) clearance on 2021-08-17, under approval number K203089.
What company makes Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System?
Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System is manufactured by Dexcom, Inc..
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.
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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
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.