Nihon Kohden OrangeMed Gets 510(k) Clearance for Its NKV-330 Ventilator

Nihon Kohden OrangeMed has received a 510(k) clearance from the FDA for its NKV-330 ventilator system.

The device offers both noninvasive and invasive ventilation as well as high-flow oxygen therapy for adult and pediatric patients. It also provides continuous monitoring of carbon dioxide when used with the company’s cap-ONE noninvasive ventilation mask.

The NKV-330 “can help hospitals who face a limited choice of new noninvasive ventilator platforms,” the company said.

Nihon Kohden America will begin shipping the NKV-330 system this month.