BEUDAMED
    FDA Registration Active 🇺🇸 United States

    MC10i Imaging System

    Reg #: 2134848 · FEI: 3003007868 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    GRANITE MICROSYSTEMS, INC.
    Registration Number
    2134848
    FEI Number
    3003007868
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    10202 NORTH ENTERPRISE DR.
    City
    MEQUON
    State
    WI
    ZIP
    53092
    Country
    US

    Regulatory Submissions

    510(k) Number
    K213303

    Owner / Operator

    Firm Name
    GRANITE MICROSYSTEMS, INC.
    Operator Number
    9039266
    Address
    10202 NORTH ENTERPRISE DR., --
    City
    Mequon
    State
    WI
    Postal Code
    53092
    Country
    US

    Products

    Device Name Product Code
    System, Imaging, Pulsed Echo, Ultrasonic IYO

    Proprietary Names

    MC10i Imaging System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)