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

    STERILIZATION OF DEVICES BY RADIATION

    K Number: K874659 · Decision Feb 2, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    108
    Registration Numbers
    108
    Same Product Code
    220
    Applicant Total
    7
    Review Days
    105

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    Basic Information

    Device Name
    STERILIZATION OF DEVICES BY RADIATION
    K Number
    K874659
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5450
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Inhalation Plastics
    Date Received
    October 20, 1987
    Decision Date
    February 2, 1988
    Product Code
    BTT
    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
    BTT Humidifier, Respiratory Gas, (Direct Patient Interface)

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    Other Clearances by Inhalation Plastics

    K Number Device Name
    K945565 SPIRO-FLEX
    K914686 THERMO-FLOW SET
    K901315 AEROMIST II NEBULIZER
    K900990 FILT-R-ALL BACTERIAL/VIRAL FILTER
    K900594 ANESTHESIA BREATHING CIRCUIT
    K896832 FILT-R-ALL BACTERIAL FILTER