510(k) K234070
K234070 is an FDA 510(k) premarket notification submitted by Dexcom, Inc. for the device "Stelo Glucose Biosensor System". The FDA issued a decision of Substantially Equivalent on March 5, 2024. The device falls under product code SAF (Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter), a Class II device regulated under 21 CFR 862.1355. Dexcom, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 5, 2024
- Date Received
- December 22, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter
- Device Class
- Class II
- Regulation Number
- 862.1355
- Review Panel
- CH
- Submission Type
An integrated continuous glucose monitoring system (iCGM) for non-intensive glucose monitoring is intended to automatically measure glucose in bodily fluids continuously or frequently for a specified period of time to detect euglycemic and dysglycemic glucose levels in persons who are not on insulin and do not have a significant risk of problematic hypoglycemia. iCGM systems for non-intensive glucose monitoring are designed to reliably and securely transmit glucose measurement data to digitally connected devices, excluding devices intended to control the delivery of insulin, and are intended to be used alone or in conjunction with these digitally connected medical devices. Device output should not be used to make treatment decisions without consulting with a qualified healthcare professional.