K261402
- 510(k) number
- K261402
- Device name
- Dexcom G7 Continuous Glucose Monitoring System;Dexcom G7 15 Day Continuous Glucose Monitoring System
- Applicant
- Dexcom, Inc. CA · US
- Product code
- QBJ — Integrated Continuous Glucose Monitoring System, Fac
- Decision date
- 2026-06-08
- Date received
- 2026-04-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K261402.pdf
Official FDA record: K261402
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.