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

    CRIT-LINE BLOOD CHAMBER WITH E-BEAM

    K Number: K935958 · Decision Jan 19, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    181
    Applicant Total
    8
    Review Days
    419

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    Basic Information

    Device Name
    CRIT-LINE BLOOD CHAMBER WITH E-BEAM
    K Number
    K935958
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    In-Line Diagnostics Corp.
    Date Received
    November 26, 1993
    Decision Date
    January 19, 1995
    Product Code
    KOC
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KOC Accessories, Blood Circuit, Hemodialysis

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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)
    K983551 CRIT-SCAN II MONITOR
    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