Mr. Gan · haixiao@sungolytest.com · +86 158 2169 5110 · +86 132 4819 8029Mr. Luo · jun.luo@sungoglobal.com · +86 177 5560 4650

K240902

Dexcom G7 Continuous Glucose Monitoring System

510(k) number
K240902
Device name
Dexcom G7 Continuous Glucose Monitoring System
Applicant
Dexcom, Inc. CA · US
Product code
QBJ — Integrated Continuous Glucose Monitoring System, Fac
Decision date
2024-04-23
Date received
2024-04-02
Decision
Substantially Equivalent
Clearance type
Special
Advisory committee
Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain

Also available from FDA: K240902.pdf

Official FDA record: K240902
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.