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

    CRIT-SCAN II MONITOR

    K Number: K983551 · Decision May 27, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    14
    Applicant Total
    8
    Review Days
    230

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    Basic Information

    Device Name
    CRIT-SCAN II MONITOR
    K Number
    K983551
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5600
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    In-Line Diagnostics Corp.
    Date Received
    October 9, 1998
    Decision Date
    May 27, 1999
    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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    Other Clearances by In-Line Diagnostics Corp.

    K Number Device Name
    K001763 CRIT-LINE MONITOR III (CLM III)
    K992227 CRIT-LINE MONITOR III (CLM III)
    K982412 MODIFICATION OF CRIT-LINE MONITOR III (CLM III)
    K972470 CRIT-LINE MONITOR (CLMIII)
    K953875 CRIT-LINE HEMATOCRIT ALERT (MODIFICATION)
    K950942 CRIT-LINE HEMATOCRIT ALERT
    K935958 CRIT-LINE BLOOD CHAMBER WITH E-BEAM