BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Ultrasound Probe

    Reg #: 3029633864 · FEI: 3029633864 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    KCL MANUFACTURING, LLC
    Registration Number
    3029633864
    FEI Number
    3029633864
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    6460 E Rogers Cir
    City
    Boca Raton
    State
    FL
    ZIP
    33487
    Country
    US

    Regulatory Submissions

    510(k) Number
    K212400

    Owner / Operator

    Firm Name
    KCL Manufacturing, LLC
    Operator Number
    10088922
    Address
    6460 E Rogers Cir
    City
    Boca Raton
    State
    FL
    Postal Code
    33487
    Country
    US
    Correspondent
    Kerry Lightcap

    Products

    Device Name Product Code
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    Transducer, Ultrasonic, Diagnostic ITX
    System, Imaging, Pulsed Echo, Ultrasonic IYO

    Proprietary Names

    Ultrasound Probe

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)