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

    MEDIBLEND (TM) LUNG DIFFUSION GAS MIXTURES

    K Number: K882210 · Decision Jun 21, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    60
    Registration Numbers
    60
    Same Product Code
    31
    Applicant Total
    6
    Review Days
    26

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    Basic Information

    Device Name
    MEDIBLEND (TM) LUNG DIFFUSION GAS MIXTURES
    K Number
    K882210
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.6400
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Linde Div. Union Carbide Corp.
    Date Received
    May 26, 1988
    Decision Date
    June 21, 1988
    Product Code
    BXK
    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
    BXK Gas, Calibration (Specified Concentration)

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    Other Clearances by Linde Div. Union Carbide Corp.

    K Number Device Name
    K882208 MEDIBLEND (TM) MEDICAL LASER GAS MIXTURES
    K882209 MEDIBLEND (TM) CLINICAL BLOOD GAS MIXTURES
    K832143 MARK III OXYGEN WALKER SYS. RESERVOIR
    K823582 OXYGEN CONCENTRATOR UCC-100
    K821841 MEDIGAS SUCTION/DRAINAGE EQUIPMENT