510(k) K051862

PC COMPATIBLE BLOOD PRESSURE MONITOR, MODEL AK-4000TU, BP-410U, BP-410R; AUTOMATIC DIGITAL WRIST BLOOD PRESS. MONITOR. by Ya Horng Electronic Co., Ltd. — Product Code DXN

K051862 is an FDA 510(k) premarket notification submitted by Ya Horng Electronic Co., Ltd. for the device "PC COMPATIBLE BLOOD PRESSURE MONITOR, MODEL AK-4000TU, BP-410U, BP-410R; AUTOMATIC DIGITAL WRIST BLOOD PRESS. MONITOR.". The FDA issued a decision of Substantially Equivalent on Aug 23, 2005. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Ya Horng Electronic Co., Ltd. has 9 other 510(k) clearances on record.