510(k) K193386

Wrist Electronic Sphygmomanometer by Shenzhen Changkun Technology Co., Ltd. — Product Code DXN

K193386 is an FDA 510(k) premarket notification submitted by Shenzhen Changkun Technology Co., Ltd. for the device "Wrist Electronic Sphygmomanometer". The FDA issued a decision of Substantially Equivalent on January 27, 2021. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Shenzhen Changkun Technology Co., Ltd. has at least 6 other 510(k) clearances on record.