510(k) K260935
- Device
- Stelo Glucose Biosensor System
- Applicant
- Dexcom, Inc.
- 510(k) number
- K260935
- Product code
- SBH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-06-12
- Date received
- 2026-03-20
- Regulation
- 862.1355
- Classification name
- Integrated Continuous Glucose Monitor For Non-Intensive Glucose Management, Over-The-Counter
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Neeta Sharma
- Address
- 6340 Sequence Dr. San Diego CA US 92121 92121
FDA Registration Numbers#
- 3011536730
Source Documents#
Other 510(k) Records For Product Code SBH#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K233861 | Libre Rio Continuous Glucose Monitoring System | Abbott Diabetes Care | 2024-06-07 |