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

    BLOOD GAS SOLUTIONS & CO-OXIMETER SOLU-

    K Number: K830843 · Decision Apr 28, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    1
    Applicant Total
    6
    Review Days
    42

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    Basic Information

    Device Name
    BLOOD GAS SOLUTIONS & CO-OXIMETER SOLU-
    K Number
    K830843
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.3220
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Rna Medical Corp.
    Date Received
    March 17, 1983
    Decision Date
    April 28, 1983
    Product Code
    JKT
    Advisory Committee
    Clinical Toxicology
    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
    JKT Gas Chromatograph, Carbon-Monoxide

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    K842519 BLOOD GAS FLUSH SOL. & FLUSH AGENT 1302
    K813447 SOLUTIONS & BUFFERS FOR BLOOD GAS INSTR