BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    SONIC MIST ULTRASONIC HUMIDIFIER

    K Number: K831646 · Decision Jul 12, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    119
    Registration Numbers
    119
    Same Product Code
    19
    Applicant Total
    1
    Review Days
    54

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    Basic Information

    Device Name
    SONIC MIST ULTRASONIC HUMIDIFIER
    K Number
    K831646
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5460
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Douglas Products
    Date Received
    May 19, 1983
    Decision Date
    July 12, 1983
    Product Code
    KFZ
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KFZ Humidifier, Non-Direct Patient Interface (Home-Use)

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