FDA.reportPublic FDA data

510(k) K234133

Device
Dexcom G7 Continuous Glucose Monitoring System
Applicant
Dexcom, Inc.
510(k) number
K234133
Product code
QBJ
Decision
Substantially Equivalent (SESE)
Decision date
2024-02-26
Date received
2023-12-29
Regulation
862.1355
Classification name
Integrated Continuous Glucose Monitoring System, Factory Calibrated
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Neeta Sharma
Address
6340 Sequence Dr. San Diego CA US 92121 92121

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code QBJ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253737Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) SystemDexcom, Inc.2026-02-03
K253710Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) SystemDexcom, Inc.2025-12-17
K243214Dexcom G7 15 Day Continuous Glucose Monitoring SystemDexcom, Inc.2025-04-09
K240902Dexcom G7 Continuous Glucose Monitoring SystemDexcom, Inc.2024-04-23
K233537FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring SystemAbbott Diabetes Care, Inc.2024-04-23
K231081Dexcom G7 Continuous Glucose Monitoring (CGM) SystemDexcom, Inc.2023-05-15
K223435FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring SystemAbbott Diabetes Care, Inc.2023-04-13
K222447FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3 Continuous Glucose Monitoring SystemAbbott Diabetes Care, Inc.2023-03-03
K223931Dexcom G6 Continuous Glucose Monitoring (CGM) SystemDexcom, Inc.2023-01-11
K213919Dexcom G7 Continuous Glucose Monitoring SystemDexcom, Inc.2022-12-07
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.2022-07-29
K201328Dexcom G6 Continuous Glucose Monitoring (CGM) SystemDexcom, Inc.2021-07-15
K200876Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring SystemDexcom, Inc.2020-12-04
K191450Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System and Dexcom Pro Q Continuous Glucose Monitoring SystemDexcom, Inc.2019-06-28
K183206Dexcom G6 Continuous Glucose Monitoring SystemDexcom, Inc.2019-02-14