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

    CORNING 2500 CO-OXIMETER

    K Number: K830590 · Decision Apr 5, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    38
    Applicant Total
    111
    Review Days
    40

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    CORNING 2500 CO-OXIMETER
    K Number
    K830590
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7500
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Corning Medical & Scientific
    Date Received
    February 24, 1983
    Decision Date
    April 5, 1983
    Product Code
    KHG
    Advisory Committee
    Hematology
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KHG Whole Blood Hemoglobin Determination

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (KHG), ordered by most recent decision date.

    AnemoCheck Home

    FDA 510(k)
    FDA Class 2 ·Hematology

    AnemoCheck

    FDA 510(k)
    FDA Class 2 ·Hematology

    ANEMIAPRO SELF-SCREENER

    FDA 510(k)
    FDA Class 2 ·Hematology

    STAT-SITE MHGB METER, STAT-SITE MHGB METER CARD HOLDER, STAT-SITE MHGB TEST CARDS, STAT-SITE MHGB CODE WAY, MODELS 90090

    FDA 510(k)
    FDA Class 2 ·Hematology

    CARESIDE HEMOGLOBIN

    FDA 510(k)
    FDA Class 2 ·Hematology

    HEMOSITE TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Hematology
    View all

    Other Clearances by Corning Medical & Scientific

    K Number Device Name
    K875122 DISPOSABLE STERILE SYRINGE FILTERS
    K872273 CORNING EASY WASH ELISA PLATES
    K872076 CORNING DISPOSABLE ROLLER BOTTLES
    K863789 CORNING ELISA PLATES
    K854024 CORNING MAGIC MAB HCG RADIOIMMUNOASSAY
    K853634 CORNING CELL WELLS-MULTIPLE WELL PLATES
    K851939 CORNING CERTAIN -ISE
    K851329 MAGIC MONOCLONAL ANTIBODY TSH(MAB TSH)RADIOIMMUNOA
    K850806 CORNING BLOOD COLLECTION CAPILLARY TUBES
    K850617 CORNING 780 FLUOROMETER/DENSITOMETER
    Search all 111 clearances from Corning Medical & Scientific →