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

    TRANSPIRATOR(TM) MT-1000 PERSONAL HUMIDIFIER

    K Number: K862919 · Decision Nov 7, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    119
    Registration Numbers
    119
    Same Product Code
    19
    Applicant Total
    1
    Review Days
    98

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    Basic Information

    Device Name
    TRANSPIRATOR(TM) MT-1000 PERSONAL HUMIDIFIER
    K Number
    K862919
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5460
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Transpirator Technologics, Inc.
    Date Received
    August 1, 1986
    Decision Date
    November 7, 1986
    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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