510(k) K192307

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

K192307 is an FDA 510(k) premarket notification submitted by Nihon Kohden Orangemed, Inc. for the device "Nihon Kohden NKV-550 Series Ventilator System". The FDA issued a decision of Substantially Equivalent on January 10, 2020. 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.