BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇺🇸 United States

    NightWare Kit, Apple iPhone, Apple Watch, Apple iPhone Charging Cable, Apple Watch Charging Cable

    K Number: DEN200033 · Decision Nov 6, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    163

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    Basic Information

    Device Name
    NightWare Kit, Apple iPhone, Apple Watch, Apple iPhone Charging Cable, Apple Watch Charging Cable
    K Number
    DEN200033
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    882.5705
    Medical Specialty
    Neurology
    Decision
    Unknown
    Applicant
    Nightware, Inc.
    Date Received
    May 27, 2020
    Decision Date
    November 6, 2020
    Product Code
    QMZ
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

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