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

    THERASTEAM PERSONAL STEAM INHALER

    K Number: K950116 · Decision Feb 10, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    119
    Registration Numbers
    119
    Same Product Code
    19
    Applicant Total
    2
    Review Days
    30

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    Basic Information

    Device Name
    THERASTEAM PERSONAL STEAM INHALER
    K Number
    K950116
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5460
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kaz, Inc.
    Date Received
    January 11, 1995
    Decision Date
    February 10, 1995
    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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