K233861
- 510(k) number
- K233861
- Device name
- Libre Rio Continuous Glucose Monitoring System
- Applicant
- Abbott Diabetes Care CA · US
- Product code
- SBH — Integrated Continuous Glucose Monitor For Non-Intens
- Decision date
- 2024-06-07
- Date received
- 2023-12-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K233861.pdf
Official FDA record: K233861
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.