BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Stelo Glucose Biosensor System

    Reg #: 3013435121 · FEI: 3013435121 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Dexcom, Inc.
    Registration Number
    3013435121
    FEI Number
    3013435121
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    232 South Dobson Road
    City
    Mesa
    State
    AZ
    ZIP
    85202
    Country
    US

    Regulatory Submissions

    510(k) Number
    K234070

    Owner / Operator

    Firm Name
    DEXCOM, INC.
    Operator Number
    9071756
    Address
    6340 Sequence Drive, --
    City
    San Diego
    State
    CA
    Postal Code
    92121
    Country
    US
    Correspondent
    Tim Peterson

    Products

    Device Name Product Code
    Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter SAF

    Proprietary Names

    Stelo Glucose Biosensor System

    Establishment Types

    Manufacture Medical Device