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510(k) Data Aggregation

    K Number
    K052715
    Device Name
    CALM CURVE, VERSION 01.00
    Date Cleared
    2005-12-22

    (84 days)

    Product Code
    Regulation Number
    884.2740
    Why did this record match?
    Applicant Name (Manufacturer) :

    LMS MEDICAL SYSTEMS (CANADA), LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    CALM Curve is intended for use as a data analysis system to assess labor progress in singleton, cephalic presentation pregnancies when the gestational age is ≥ 35 weeks.
    Device Description
    CALM Curve is a computerized method to assess progress during labor. Its algorithms calculate the patient's progress based on user-entered values for parity, dilatation, effacement, station, contraction frequency, and epidural use. Results of these calculations are displayed graphically and as percentile values derived from comparison to a database of women with similar characteristics who delivered vaginally. CALM Curve is intended for use as a data analysis system to assess labor progress in singleton, cephalic presentation pregnancies when the gestational age is > 35 weeks. CALM Curve can function in a networked environment, as a standalone workstation, or as a web-based application. When connected to a fetal monitor, CALM Curve can use the monitor's uterine activity signal in lieu of user-entered values to calculate contraction counts.
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