510(k) K222644

Nihon Kohden NKV-440 Ventilator System by Nihon Kohden Orangemed, Inc. — Product Code CBK

K222644 is an FDA 510(k) premarket notification submitted by Nihon Kohden Orangemed, Inc. for the device "Nihon Kohden NKV-440 Ventilator System". The FDA issued a decision of Substantially Equivalent on May 31, 2023. The device falls under product code CBK (Ventilator, Continuous, Facility Use), a Class II device regulated under 21 CFR 868.5895. Nihon Kohden Orangemed, Inc. has at least 4 other 510(k) clearances on record.