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510(k) Data Aggregation
K Number
K082704Device Name
BIRTHTRACK (A.K.A. CLM)
Manufacturer
BARNEV, LTD.
Date Cleared
2009-01-09
(115 days)
Product Code
NPB
Regulation Number
884.2800Why 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
K080672Device Name
BIRTHTRACK
Manufacturer
BARNEV, LTD.
Date Cleared
2008-07-08
(120 days)
Product Code
NPB
Regulation Number
884.2800Why 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.
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K Number
DEN060006Device Name
COMPUTERIZED LABOR MONITORING SYSTEM
Manufacturer
BARNEV, LTD.
Date Cleared
2007-01-30
(104 days)
Product Code
NPB
Regulation Number
884.2800Why did this record match?
Applicant Name (Manufacturer) :
BARNEV, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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