BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    NeuroFortis NeuroSmart Drive Headstage

    Reg #: 9615126 · FEI: 3001610756 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    18
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ALPHA OMEGA ENGINEERING LTD.
    Registration Number
    9615126
    FEI Number
    3001610756
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Hamerkava St. 6, Tsiporit Industrial Zone
    City
    Nof HaGalil Northern
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K172042

    Owner / Operator

    Firm Name
    ALPHA OMEGA ENGINEERING LTD.
    Operator Number
    9039414
    Address
    Hamerkava st.6, Tsiporit Industrial Zone
    City
    Nof HaGalil (Nazareth Illit)
    State
    Northern
    Postal Code
    1789062
    Country
    IL

    Products

    Device Name Product Code
    Electrode, Depth GZL

    Proprietary Names

    NeuroFortis NeuroSmart Drive Headstage NeuroSmart NeuroNav Drive Headstage NeuroNav NeuroNav MER Headstage NeuroSmart MER Headstage NeuroSmart Autoclavable Drive Headstage Kit NeuroNav with Autoclavable Drive Headstage NeuroNav with NeuroFortis Drive NeuroNav with NeuroNav Drive NeuroNav Drive Headstage Kit NeuroSmart MER Headstage Kit NeuroSmart Autoclavable Drive Headstage NeuroFortis NeuroSmart Drive Headstage Kit NeuroNav MER Headstage Kit NeuroSmart with NeuroFortis Drive NeuroNav with MER Headstage NeuroSmart with AutoClavable Drive Headstage

    Establishment Types

    Manufacture Medical Device