FDA.report

510(k) K243214

Device
Dexcom G7 15 Day Continuous Glucose Monitoring System
Applicant
Dexcom, Inc.
510(k) number
K243214
Product code
QBJ
Decision
Substantially Equivalent (SESE)
Decision date
2025-04-09
Date received
2024-10-03
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
N

Related Records

Applicant Contact

Contact
Holly Drake
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)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
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
K234133Dexcom G7 Continuous Glucose Monitoring SystemDexcom, Inc.2024-02-26
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