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

    BLOOD GAS FLUSH SOL. & FLUSH AGENT 1302

    K Number: K842519 · Decision Aug 17, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    187
    Applicant Total
    6
    Review Days
    38

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    Basic Information

    Device Name
    BLOOD GAS FLUSH SOL. & FLUSH AGENT 1302
    K Number
    K842519
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1120
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Rna Medical Corp.
    Date Received
    July 10, 1984
    Decision Date
    August 17, 1984
    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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    Other Clearances by Rna Medical Corp.

    K Number Device Name
    K851362 STANDARD SOLUTION OF CONDUCTIVITY & MEASUREMENT OF
    K844589 OSMOLARITY STANDARDS
    K842131 FORMACLEAR- & MULTIPLE
    K830843 BLOOD GAS SOLUTIONS & CO-OXIMETER SOLU-
    K813447 SOLUTIONS & BUFFERS FOR BLOOD GAS INSTR