BEUDAMED
    FDA Registration Active 🇺🇸 United States

    MEGA-TMS

    Reg #: 3012182497 · FEI: 3012182497 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    SOTERIX MEDICAL,INC.
    Registration Number
    3012182497
    FEI Number
    3012182497
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1480 US Highway 9 North, 204
    City
    Woodbridge
    State
    NJ
    ZIP
    07095
    Country
    US

    Regulatory Submissions

    510(k) Number
    K192823

    Owner / Operator

    Firm Name
    Soterix Medical,Inc.
    Operator Number
    10054978
    Address
    1480 US Highway 9 North, 204
    City
    Woodbridge
    State
    NJ
    Postal Code
    07095
    Country
    US
    Correspondent
    Abhishek Datta

    Products

    Device Name Product Code
    Device, Nerve Conduction Velocity Measurement JXE
    Stimulator, Electrical, Evoked Response GWF

    Proprietary Names

    MEGA-TMS

    Establishment Types

    Manufacture Medical Device