510(k) K043531

MODIFICATION TO ARM BLOOD PRESSURE MONITOR, MODELS KP-6821, KP-6822 by K-Jump Health Co., Ltd. — Product Code DXN

K043531 is an FDA 510(k) premarket notification submitted by K-Jump Health Co., Ltd. for the device "MODIFICATION TO ARM BLOOD PRESSURE MONITOR, MODELS KP-6821, KP-6822". The FDA issued a decision of Substantially Equivalent on April 21, 2005. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. K-Jump Health Co., Ltd. has at least 10 other 510(k) clearances on record.