Stelo Glucose Biosensor System— 510(k) K262472
Substantially EquivalentDexcom, Inc.
FDA 510(k) clearance K262472 for Stelo Glucose Biosensor System, Substantially Equivalent on 2026-08-11. Applicant: Dexcom, Inc.. Device class: 2.
Clearance details
- Applicant
- Dexcom, Inc.
- Product code
- Code SBH
- Device class
- Class 2
- Regulation
- 21 CFR 862.1355
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- San Diego, CA, US
Recent devices under product code SBH
view allMore clearances from Dexcom, Inc.
view all- K261402 — Dexcom G7 Continuous Glucose Monitoring System; Dexcom G7 15 Day Continuous Glucose Monitoring System
- K261359 — Stelo Glucose Biosensor System
- K253737 — Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System
- K253710 — Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System
- K252818 — Dexcom Smart Basal
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