BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    Harmonic ACE

    Reg #: 3010157088 · FEI: 3010157088 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Device Technologies Australia
    Registration Number
    3010157088
    FEI Number
    3010157088
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    30 Graystone Street
    City
    Tingalpa Queensland
    Country
    AU

    Regulatory Submissions

    510(k) Number
    K143132

    Owner / Operator

    Firm Name
    Intuitive Surgical, Inc.
    Operator Number
    9028901
    Address
    1266 Kifer Road, --
    City
    Sunnyvale
    State
    CA
    Postal Code
    94086
    Country
    US

    Products

    Device Name Product Code
    System, Surgical, Computer Controlled Instrument NAY
    Instrument, Ultrasonic Surgical LFL

    Proprietary Names

    Harmonic ACE

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device