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

    STAT-CRIT HEMATOCRIT MEASURING INSTRU

    K Number: K802199 · Decision Feb 4, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    14
    Applicant Total
    218
    Review Days
    147

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    Basic Information

    Device Name
    STAT-CRIT HEMATOCRIT MEASURING INSTRU
    K Number
    K802199
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5600
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    United States Surgical, A Division of Tyco Healthc
    Date Received
    September 10, 1980
    Decision Date
    February 4, 1981
    Product Code
    GKF
    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
    GKF Instrument, Hematocrit, Automated

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