510(k) K040528

AMLUCK YA HORNG PC COMPATIBLE WRIST BLOOD PRESSURE MONITOR, MODEL AK-4000T by Ya Horng Electronic Co., Ltd. — Product Code DXN

K040528 is an FDA 510(k) premarket notification submitted by Ya Horng Electronic Co., Ltd. for the device "AMLUCK YA HORNG PC COMPATIBLE WRIST BLOOD PRESSURE MONITOR, MODEL AK-4000T". The FDA issued a decision of Substantially Equivalent on Apr 15, 2004. 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.