510(k) K152305

Nihon Kohden Afib Detection Program QP-039P by Nihon Kohden Corporation — Product Code DSI

K152305 is an FDA 510(k) premarket notification submitted by Nihon Kohden Corporation for the device "Nihon Kohden Afib Detection Program QP-039P". The FDA issued a decision of Substantially Equivalent on April 8, 2016. The device falls under product code DSI (Detector And Alarm, Arrhythmia), a Class II device regulated under 21 CFR 870.1025. Nihon Kohden Corporation has at least 10 other 510(k) clearances on record.