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

    CRIT-LINE MONITOR III TQA (CLM TQA)

    K Number: K011741 · Decision Jul 23, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    7
    Applicant Total
    1
    Review Days
    413

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    Basic Information

    Device Name
    CRIT-LINE MONITOR III TQA (CLM TQA)
    K Number
    K011741
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hemametrics
    Date Received
    June 5, 2001
    Decision Date
    July 23, 2002
    Product Code
    FIL
    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
    FIL System, Dialysate Delivery, Single Pass

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