510(k) clearance
MODI System
- 510(k) number
- K260062
- Applicant
- DreaMed Diabetes, Ltd.
- Decision date
- Sep 8, 2026
- Date received
- Jan 8, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- QRX
- Device type
- Continuous Glucose Monitor Informed Insulin Dose Calculator
- Device class
- Class II
- Regulation
- 21 CFR 862.1358
- Advisory committee
- Clinical Chemistry
- Statement or summary
- Summary
- Third party
- N
- Location
- Petah Tikva, IL