K234055
- 510(k) number
- K234055
- Device name
- DEKA Loop
- Applicant
- Deka Research and Development NH · US
- Product code
- QJI — Interoperable Automated Glycemic Controller
- Decision date
- 2024-03-13
- Date received
- 2023-12-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K234055.pdf
Official FDA record: K234055
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.