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Monitoring System For Progress Of Labor Suppliers

  1 suppliers  
Barnev Ltd. | Address: 8 Hamelacha Str., Pob 8694, Netanya 42504, Israel
Phone: +972-(9)-8923130
Products: Colposcopes, Vaginal examination, Women's Health Products, Patient Monitoring Devices, Medical Equipment Service, Infant Care Units, Monitoring System For Progress Of Labor (FDA Code: NPB), Portable Patient Monitor with Touch-Screen, ...
Barnev Ltd. is a medical device company dedicated to improving women's healthcare through the development, production and marketing of cutting edge, real-time obstetric monitoring devices. We offer a more...
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  1 Monitoring System For Progress Of Labor suppliers  
FDA Code / Regulation: NPB / 884.2800

A computerized labor monitoring system is a system intended to continuously measure cervical dilation and fetal head descent and provide a display that indicates the progress of labor. The computerized labor monitoring system includes a monitor and ultrasound transducers. Ultrasound transducers are placed on the maternal abdomen and cervix and on the fetal scalp to provide the matrix of measurements used to produce the display.

Classification. Class II (special controls). The special controls are the FDA guidance document entitled: "Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Computerized Labor Monitoring Systems." See 884.1(e) for availability of this guidance document.

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