K250930
- 510(k) number
- K250930
- Device name
- twiist system
- Applicant
- Deka Research & Development Corp. NH · US
- Product code
- QFG — Alternate Controller Enabled Insulin Infusion Pump
- Decision date
- 2025-04-02
- Date received
- 2025-03-28
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K250930.pdf
Official FDA record: K250930
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.