BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Halo Catalyst Ultrasound System

    Reg #: 3010933511 · FEI: 3010933511 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    HALO MEDICAL TECHNOLOGIES
    Registration Number
    3010933511
    FEI Number
    3010933511
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2436 Emrick Blvd
    City
    Bethlehem
    State
    PA
    ZIP
    18020
    Country
    US

    Regulatory Submissions

    510(k) Number
    K140899

    Owner / Operator

    Firm Name
    Halo Medical Technologies
    Operator Number
    10047080
    Address
    2436 Emrick Blvd
    City
    Bethlehem
    State
    PA
    Postal Code
    18020
    Country
    US
    Correspondent
    Clare M Rosa

    Products

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

    Proprietary Names

    Halo Catalyst Ultrasound System

    Establishment Types

    Manufacture Medical Device