K243214
- 510(k) number
- K243214
- Device name
- Dexcom G7 15 Day Continuous Glucose Monitoring System
- Applicant
- Dexcom, Inc. CA · US
- Product code
- QBJ — Integrated Continuous Glucose Monitoring System, Fac
- Decision date
- 2025-04-09
- Date received
- 2024-10-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K243214.pdf
Official FDA record: K243214
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.