K251152
- 510(k) number
- K251152
- Device name
- DBLG2
- Applicant
- Diabeloop FR
- Product code
- QJI — Interoperable Automated Glycemic Controller
- Decision date
- 2025-12-19
- Date received
- 2025-04-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K251152.pdf
Official FDA record: K251152
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.