BEUDAMED
    FDA Registration Active 🇺🇸 United States

    NEUROWAVE SYSTEMS INC.

    Reg #: 3008657519 · FEI: 3008657519 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    5

    Registration Details

    Registration Name
    NEUROWAVE SYSTEMS INC.
    Registration Number
    3008657519
    FEI Number
    3008657519
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    25825 Science Park Dr, STE 250
    City
    Beachwood
    State
    OH
    ZIP
    44122
    Country
    US

    Regulatory Submissions

    510(k) Number
    K202621

    Owner / Operator

    Firm Name
    NeuroWave Systems Inc.
    Operator Number
    10033810
    Address
    25825 Science Park, STE 250
    City
    Beachwood
    State
    OH
    Postal Code
    44122
    Country
    US
    Correspondent
    Tatjana Zikov

    Products

    Device Name Product Code
    Burst Suppression Detection Software For Electroencephalograph ORT
    Electrode, Cutaneous GXY
    Reduced- Montage Standard Electroencephalograph OMC
    Non-Normalizing Quantitative Electroencephalograph Software OLT
    Index-Generating Electroencephalograph Software OLW

    Proprietary Names

    NeuroSENSE Monitoring System, Model NS-901, with EasyPrep Electrodes EK-901

    Establishment Types

    Manufacture Medical Device