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

    Neoasis

    K Number: DEN220048 · Decision Jun 16, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    2
    Review Days
    326

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    Basic Information

    Device Name
    Neoasis
    K Number
    DEN220048
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    880.5405
    Medical Specialty
    General Hospital
    Decision
    Unknown
    Applicant
    Invictus Medical, Inc.
    Date Received
    July 25, 2022
    Decision Date
    June 16, 2023
    Product Code
    QWX
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    QWX Active Noise Attenuation System For Infant Incubators

    Other Clearances by Invictus Medical, Inc.

    K Number Device Name
    K150243 Invictus Medical GelShield