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

    VIROTHERM HUMIDIFIER

    K Number: K915603 · Decision Oct 22, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    119
    Registration Numbers
    119
    Same Product Code
    19
    Applicant Total
    1
    Review Days
    311

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    Basic Information

    Device Name
    VIROTHERM HUMIDIFIER
    K Number
    K915603
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5460
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Virotherm Laboratory
    Date Received
    December 16, 1991
    Decision Date
    October 22, 1992
    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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