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

Nihon Kohden OrangeMed Inc. has 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 the 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 health care 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.

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