Nihon Kohden NKV-330 Ventilator System Receives US FDA 510(k) Clearance

IRVINE, Calif.--(BUSINESS WIRE)-- 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. This system offers invasive and non-invasive ventilation, as well as high flow oxygen therapy. In addition, it provides continuous monitoring of CO₂ when using our cap-ONE^® NIV mask. The cap-ONE mask is an NIV interface that allows quality CO₂ monitoring directly from the ventilator.

“The NKV-330 ventilator can help hospitals who face a limited choice of new non-invasive ventilator platforms for adult and pediatric patients,” said Eiichi Tanaka, President and CEO of Nihon Kohden America. “This new platform offers a seamless transition between non-invasive therapy and high flow oxygen therapy to meet the changing needs of patients. The continuous monitoring of ETCO₂, the excellent portability, dual HEPA filtration, ‘hot-swap’ battery, and many other features in the NKV-330 makes it a great choice for hospitals and healthcare providers.”

The NKV-330 Ventilator System is distributed in the United States by Nihon Kohden America, Inc. and is expected to begin shipping in July 2022. It has been available outside of the United States since 2019.

More information on the NKV-330 Ventilator System can be found here at Orange-Med.com.

About Nihon Kohden Corporation

Founded in Japan in 1951, Nihon Kohden is a leading manufacturer, developer, and distributor of medical electronic equipment, with subsidiaries in the U.S., Europe, Asia, and Latin America. The company’s products are now used in more than 120 countries, and it is the largest supplier of electroencephalography products worldwide. A pioneer in transformational healthcare technology, Nihon Kohden has envisioned, designed, and produced revolutionary devices, such as pulse oximeters, arrhythmia analysis, low-invasive blood volume monitoring and wireless patient monitoring. For more information, visit us.nihonkohden.com.

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