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

    MEDIBLEND (TM) CLINICAL BLOOD GAS MIXTURES

    K Number: K882209 · Decision Aug 2, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    187
    Applicant Total
    6
    Review Days
    68

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    Basic Information

    Device Name
    MEDIBLEND (TM) CLINICAL BLOOD GAS MIXTURES
    K Number
    K882209
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1120
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Linde Div. Union Carbide Corp.
    Date Received
    May 26, 1988
    Decision Date
    August 2, 1988
    Product Code
    CHL
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph

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    K832143 MARK III OXYGEN WALKER SYS. RESERVOIR
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