BEUDAMED
    FDA Registration Active 🇺🇸 United States

    NIGHTWARE

    Reg #: 3017660607 · FEI: 3017660607 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    0
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    NIGHTWARE
    Registration Number
    3017660607
    FEI Number
    3017660607
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    8900 EXCELSIOR BLVD
    City
    Hopkins
    State
    MN
    ZIP
    55343
    Country
    US

    Regulatory Submissions

    510(k) Number
    DEN200033

    Owner / Operator

    Firm Name
    NightWare
    Operator Number
    10079063
    Address
    8900 EXCELSIOR BLVD
    City
    Hopkins
    State
    MN
    Postal Code
    55343
    Country
    US

    Products

    Device Name Product Code
    Digital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions QMZ

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device