K253737
- 510(k) number
- K253737
- Device name
- Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System
- Applicant
- Dexcom, Inc. CA · US
- Product code
- QBJ — Integrated Continuous Glucose Monitoring System, Fac
- Decision date
- 2026-02-03
- Date received
- 2025-11-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K253737.pdf
Official FDA record: K253737
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.