K231824
- 510(k) number
- K231824
- Device name
- SmartBolus Calculator
- Applicant
- Insulet Corporation MA · US
- Product code
- QRX — Continuous Glucose Monitor Informed Insulin Dose Cal
- Decision date
- 2023-10-18
- Date received
- 2023-06-21
- 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: K231824.pdf
Official FDA record: K231824
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.