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

    RADIOMETER ACID BASE LABORATORY-ABL-3

    K Number: K800224 · Decision Feb 22, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    187
    Applicant Total
    7
    Review Days
    17

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    Basic Information

    Device Name
    RADIOMETER ACID BASE LABORATORY-ABL-3
    K Number
    K800224
    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
    February 5, 1980
    Decision Date
    February 22, 1980
    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 The London Co.

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    K780652 HEMOGLOBIN CHECK SOLUTIONS, S2100 OSM-2
    K771444 QUALICHECK TM
    K771263 RADIOMHTER OSM-2 HEMOXIMETER
    K760229 ACID BASE SYSTEM, RADIOMETER AUTOMATED