K241777
- 510(k) number
- K241777
- Device name
- SmartAdjust Technology
- Applicant
- Insulet Corporation MA · US
- Product code
- QJI — Interoperable Automated Glycemic Controller
- Decision date
- 2024-08-26
- Date received
- 2024-06-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K241777.pdf
Official FDA record: K241777
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.