BEUDAMED
    FDA Registration Active 🇺🇸 United States

    HD03 Hemdialysis Monitor

    Reg #: 1319030 · FEI: 1319030 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    TRANSONIC SYSTEMS, INC.
    Registration Number
    1319030
    FEI Number
    1319030
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    34 Dutch Mill Rd
    City
    ITHACA
    State
    NY
    ZIP
    14850
    Country
    US

    Regulatory Submissions

    510(k) Number
    K960817

    Owner / Operator

    Firm Name
    TRANSONIC SYSTEMS, INC.
    Operator Number
    1319030
    Address
    34 Dutch Mill Road
    City
    Ithaca
    State
    NY
    Postal Code
    14850
    Country
    US
    Correspondent
    Elizabeth Emig-Rosekrans

    Products

    Device Name Product Code
    System, Hemodialysis, Access Recirculation Monitoring MQS

    Proprietary Names

    HD03 Hemdialysis Monitor HD02 Hemodialysis Monitor HD01 Hemodialysis Monitor HD02-E Hemodialysis Monitor

    Establishment Types

    Manufacture Medical Device