BEUDAMED
    FDA Registration Active 🇺🇸 United States

    RX100

    Reg #: 3004081884 · FEI: 3004081884 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    CLEAR BLUE ENGINEERING, INC.
    Registration Number
    3004081884
    FEI Number
    3004081884
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1650 Coal Creek Dr., Suite E
    City
    Lafayette
    State
    CO
    ZIP
    80026
    Country
    US

    Regulatory Submissions

    510(k) Number
    K093259

    Owner / Operator

    Firm Name
    Clear Blue Engineering, Inc.
    Operator Number
    10081047
    Address
    1650 Coal Creek Dr., Suite E
    City
    Lafayette
    State
    CO
    Postal Code
    80026
    Country
    US
    Correspondent
    Daniel Minardi

    Products

    Device Name Product Code
    Stimulator, Muscle, Powered IPF

    Proprietary Names

    RX100 RX Black

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)