Today, Nihon Kohden OrangeMed, Inc. received U.S. Food and Drug Administration (FDA) 510(k) clearance for its NKV-440 Ventilator System. The NKV-440, an turbine-based ventilator, is a “neonatal through adult” platform that provides independence from compressed air while providing high-quality ICU performance in a smaller, more...
Today, Nihon Kohden OrangeMed, Inc. received U.S. Food and Drug Administration (FDA) 510(k) clearance for its NKV-330 Ventilator System. The NKV-330 is a non-invasive ventilator that provides respiratory support to adult and pediatric patients. It offers not only non-invasive ventilation but also invasive ventilation as...
Nihon Kohden OrangeMed, Inc. announced it was selected by U.S. Army’s Telemedicine and Advanced Technology Research Center (TATRC) at the U.S. Army Medical Research and Development Command to develop ventilator remote control technology for the National Emergency Tele-Critical Care Network (NETCCN). The agreement was issued...
TOKYO, JAPAN - The Nihon Kohden Group has begun worldwide shipments of the Protective Control® feature for their NKV-550 ventilators. Protective Control is a second user interface placed outside of the isolated patient’s room, in addition to the primary user interface on the ventilator next to...
Today, Nihon Kohden OrangeMed has received ISO 13485:2016 certification for its quality management system (QMS) following an extensive review by DEKRA. An internationally recognized QMS standard, ISO 13485 was specifically developed for medical device companies. Certification indicates a demonstrated ability to design and manufacture quality...
Nihon Kohden OrangeMed, Inc. has received U.S. FDA 510(k) clearance for the Nihon Kohden NKV-550 Series Ventilator System. The NKV-550 Series Ventilator System is a critical care ventilator designed for adult, pediatric or neonatal patients for use in a hospital or hospital-type setting. Ventilation is...