K250106
- 510(k) number
- K250106
- Device name
- Signos Glucose Monitoring System
- Applicant
- Signos, Inc. CA · US
- Product code
- SAF — Integrated Continuous Glucose Monitor For Non-Intens
- Decision date
- 2025-03-21
- Date received
- 2025-01-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
510(k) Summary (official FDA PDF): K250106.pdf
Official FDA record: K250106
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.