Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System
K-Number: K253737 · 2026-02-03
ApplicantDexcom, Inc.
Decision Date2026-02-03
Product CodeQBJ
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System is a medical device manufactured by Dexcom, Inc.. It received FDA 510(k) clearance on 2026-02-03 under approval number K253737. 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 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. It is manufactured by Dexcom, Inc.. The 510(k) number is K253737.
When was Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System approved by the FDA?
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 approval number K253737.
What company makes 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 manufactured by Dexcom, Inc..
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.
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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.
K200876Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring SystemDexcom, Inc.
K201328Dexcom G6 Continuous Glucose Monitoring (CGM) SystemDexcom, Inc.
K213919Dexcom G7 Continuous Glucose Monitoring SystemDexcom, Inc.
Official Source
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