K232224
- 510(k) number
- K232224
- Device name
- iLet® Dosing Decision Software
- Applicant
- Beta Bionics, Inc. MA · US
- Product code
- QJI — Interoperable Automated Glycemic Controller
- Decision date
- 2023-09-22
- Date received
- 2023-07-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 2.4 MB · U.S. public domain
Also available from FDA: K232224.pdf
Official FDA record: K232224
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.