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510(k) Data Aggregation
K Number
K130002Device Name
SURECALL LABOR MONITOR
Manufacturer
REPRODUCTIVE RESEARCH TECHNOLOGIES, LP
Date Cleared
2013-06-28
(177 days)
Product Code
OSP
Regulation Number
884.2720Why did this record match?
Applicant Name (Manufacturer) :
REPRODUCTIVE RESEARCH TECHNOLOGIES, LP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SureCALL® Labor Monitor® is a transabdominal electromyography (EMG) monitor intended to measure uterine activity. It is intended for use on pregnant women who are at term (>36 completed weeks), with singleton pregnancies, using surface electrodes on the maternal abdomen. The device is intended for use by healthcare professionals in a clinical setting.
Device Description
The SureCALL® Labor Monitor® is a transabdominal electromyography monitor. The device consists of a Signal Conditioning Module specifically designed to collect, filter, and amplify the electromyographic (EMG) signal and a separate Control System to analyze, record, and display the EMG signal. In addition, the device has the option to record and display the input from standard FDA-cleared fetal heart rate sensor, intrauterine pressure catheter, and maternal heart rate sensor or tocodynamometers transducer device, alongside the EMG signal traces. The Signal Conditioning Module contains electronic components designed to receive a physiological signal from a set of Ag/AgCI surface electrodes placed on the subject's abdomen and amplify and filter the signal. The optional fetal heart rate, intrauterine pressure catheter, and maternal heart rate or tocodynamometer's signals originating and collected from FDA-cleared devices pass through the Signal Conditioning Module without modification. The Control System consists of an off-the-shelf laptop computer with a LabVIEW based program designed to collect, record and display electrical signals in a meaningful and easily quantifiable format.
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K Number
K090145Device Name
SURECALL EMG LABOR MONITOR
Manufacturer
REPRODUCTIVE RESEARCH TECHNOLOGIES, LP
Date Cleared
2011-01-25
(734 days)
Product Code
OSP
Regulation Number
884.2720Why did this record match?
Applicant Name (Manufacturer) :
REPRODUCTIVE RESEARCH TECHNOLOGIES, LP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SureCALL® EMG Labor Monitor® is a transabdominal electromyography (EMG) monitor intended to measure intrapartum uterine activity. It is intended for use on women who are at term (>36 completed weeks), in labor, with singleton pregnancies, using surface electrodes on the maternal abdomen. The device is intended for use by healthcare professionals in a clinical setting.
Device Description
The SureCALL® EMG Labor Monitor® is a transabdominal electromyography monitor. The device consists of a Signal Conditioning Module specifically designed to collect. filter, and amplify the electromyographical (EMG) signal and a separate Control System to analyze, record, and display the EMG signal. In addition, the device records and displays the input from standard FDA-cleared maternal heart rate sensor, fetal, heart rate sensor, intrauterine pressure catheter and tocodynamometer transducer devices, along side the EMG signal traces. The Signal Conditioning Module contains electronic components designed to receive a physiological signal from a set of Ag/AgCl surface electrodes placed on the subject's abdomen and amplify and filter the signal. The heart rate, intrauterine pressure, and/or tocodynamometer signals originating and collected from FDA-cleared devices pass through the Signal Conditioning Module without modification. The Control System consists of an off-the-shelf laptop computer with a LabVIEW based program designed to collect, record and display electrical signals in a meaningful and quantifiable format.
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