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

    ACID BASE SYSTEM, RADIOMETER AUTOMATED

    K Number: K760229 · Decision Aug 26, 1976
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    187
    Applicant Total
    7
    Review Days
    43

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    Basic Information

    Device Name
    ACID BASE SYSTEM, RADIOMETER AUTOMATED
    K Number
    K760229
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1120
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    The London Co.
    Date Received
    July 14, 1976
    Decision Date
    August 26, 1976
    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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