Profile: Clinical Computer Systems, Inc. specializes in developing, manufacturing and marketing of Obix® perinatal data systems used in medical applications. It is used in hospitals for hospital-wide charting solutions and for electronic medical record repositories. It is a computerized system for central, bedside and remote EFM monitoring, which includes archiving, point-of-care charting, single-click management reports and internet-based physician access. The real-time charting module of the system offers charting capabilities without space-consuming workstations.
The company is ISO 13485:2003,ISO 9001:2000 certified.
FDA Registration Number: 3004423584
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| • Perinatal Monitoring System (FDA Code: HGM / 884.2740) A perinatal monitoring system is a device used to show graphically the relationship between maternal labor and the fetal heart rate by means of combining and coordinating uterine contraction and fetal heart monitors with appropriate displays of the well-being of the fetus during pregnancy, labor, and delivery. This generic type of device may include any of the devices subject to 884.2600, 884.2640, 884.2660, 884.2675, 884.2700, and 884.2720. This generic type of device may include the following accessories: Central monitoring system and remote repeaters, signal analysis and display equipment, patient and equipment supports, and component parts. |