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510(k) Data Aggregation

    K Number
    K082704
    Device Name
    BIRTHTRACK (A.K.A. CLM)
    Manufacturer
    BARNEV, LTD.
    Date Cleared
    2009-01-09

    (115 days)

    Product Code
    NPB
    Regulation Number
    884.2800
    Why did this record match?
    Applicant Name (Manufacturer) :

    BARNEV, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BirthTrack System is an ultrasound device intended to be used for monitoring the active phase of labor in women with term pregnancies, vertex presentation, and ruptured membranes. It is intended to be placed when cervical dilation is between 3 cm and 7 cm. The device continuously measures cervical dilation and fetal head station with ultrasound transducers attached to the maternal abdomen and cervix and to the fetal scalp. These measurements are displayed numerically and graphically as a function of time to show the progress of labor.
    Device Description
    Barnev's BirthTrack system uses ultrasound technology to provide measurements of cervix dilatation and fetal head station. The BirthTrack Workflow and measurements cycle have not changed with this version and signals from disposable sensors located on the maternal cervix and fetal head provide objective and continuous cervical dilatation and fetal head station data, reducing the need for frequent vaginal examinations. However signal analysis was enhanced with a new algorithm- a "side inclination" correction algorithm. The system's GUI was also enhanced introducing a graphic illustration of CD and HS as measured by the BirthTrack system
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    K Number
    K080672
    Device Name
    BIRTHTRACK
    Manufacturer
    BARNEV, LTD.
    Date Cleared
    2008-07-08

    (120 days)

    Product Code
    NPB
    Regulation Number
    884.2800
    Why did this record match?
    Applicant Name (Manufacturer) :

    BARNEV, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BirthTrack System is an ultrasound device intended to be used for monitoring the active phase of labor in women with term pregnancies, vertex presentation, and ruptured membranes. It is intended to be placed when cervical dilation is between 3 cm and 7 cm. The device continuously measures cervical dilation and fetal head station with ultrasound transducers attached to the maternal abdomen and cervix and to the fetal scalp. These measurements are displayed numerically and graphically as a function of time to show the progress of labor.
    Device Description
    Barnev's BirthTrack system uses ultrasound technology to provide measurements of cervix dilatation and fetal head station. Signals from disposable sensors located on the maternal cervix and fetal head provide objective and continuous cervical dilatation and fetal head station data, reducing the need for frequent vaginal examinations.
    Ask a Question
    K Number
    DEN060006
    Device Name
    COMPUTERIZED LABOR MONITORING SYSTEM
    Manufacturer
    BARNEV, LTD.
    Date Cleared
    2007-01-30

    (104 days)

    Product Code
    NPB
    Regulation Number
    884.2800
    Why did this record match?
    Applicant Name (Manufacturer) :

    BARNEV, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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