FDA.reportPublic FDA data

510(k) K234070

Device
Stelo Glucose Biosensor System
Applicant
Dexcom, Inc.
510(k) number
K234070
Product code
SAF
Decision
Substantially Equivalent (SESE)
Decision date
2024-03-05
Date received
2023-12-22
Regulation
862.1355
Classification name
Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Neeta Sharma
Address
6340 Sequence Dr. San Diego CA US 92121 92121

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code SAF#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K261359Stelo Glucose Biosensor SystemDexcom, Inc.2026-05-21
K250106Signos Glucose Monitoring SystemSignos, Inc.2025-03-21
K233655Lingo Glucose SystemAbbott2024-05-29