510(k) K062462

NON-INVASIVE BLOOD PRESSURE MONITOR, MODELS FT-500R/L AND FT-700R/L by Jawon Medical Co., Ltd. — Product Code DXN

K062462 is an FDA 510(k) premarket notification submitted by Jawon Medical Co., Ltd. for the device "NON-INVASIVE BLOOD PRESSURE MONITOR, MODELS FT-500R/L AND FT-700R/L". The FDA issued a decision of Substantially Equivalent on September 29, 2006. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Jawon Medical Co., Ltd. has at least 10 other 510(k) clearances on record.