510(k) K202757

CONTEC08A Electronic Sphygmomanometer, CONTEC08C Electronic Sphygmomanometer, ABPM50 Automatic Blood Pressure Monitor by Contec Medical Systems Co.,Ltd — Product Code DXN

K202757 is an FDA 510(k) premarket notification submitted by Contec Medical Systems Co.,Ltd for the device "CONTEC08A Electronic Sphygmomanometer, CONTEC08C Electronic Sphygmomanometer, ABPM50 Automatic Blood Pressure Monitor". The FDA issued a decision of Substantially Equivalent on April 28, 2021. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Contec Medical Systems Co.,Ltd has at least 10 other 510(k) clearances on record.