K250798
- 510(k) number
- K250798
- Device name
- Control-IQ+ technology
- Applicant
- Tandem Diabetes Care, Inc. CA · US
- Product code
- QJI — Interoperable Automated Glycemic Controller
- Decision date
- 2025-05-21
- Date received
- 2025-03-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K250798.pdf
Official FDA record: K250798
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.