510(k) K231778

Nihon Kohden NKV-550 Series Ventilator System by Nihon Kohden Orangemed, LLC — Product Code CBK

K231778 is an FDA 510(k) premarket notification submitted by Nihon Kohden Orangemed, LLC for the device "Nihon Kohden NKV-550 Series Ventilator System". The FDA issued a decision of Substantially Equivalent on March 1, 2024. The device falls under product code CBK (Ventilator, Continuous, Facility Use), a Class II device regulated under 21 CFR 868.5895. Nihon Kohden Orangemed, LLC has at least 4 other 510(k) clearances on record.