K233655
- 510(k) number
- K233655
- Device name
- Lingo Glucose System
- Applicant
- Abbott CA · US
- Product code
- SAF — Integrated Continuous Glucose Monitor For Non-Intens
- Decision date
- 2024-05-29
- Date received
- 2023-11-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
510(k) Summary (official FDA PDF): K233655.pdf
Official FDA record: K233655
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.