510(k) K161886

Transtek Blood Pressure Monitor, Welch Allyn Remote Monitoring Blood Pressure Device, Welch Allyn Home Blood Pressure Device by Guangdong Transtek Medical Electronics Co., Ltd. — Product Code DXN

K161886 is an FDA 510(k) premarket notification submitted by Guangdong Transtek Medical Electronics Co., Ltd. for the device "Transtek Blood Pressure Monitor, Welch Allyn Remote Monitoring Blood Pressure Device, Welch Allyn Home Blood Pressure Device". The FDA issued a decision of Substantially Equivalent on October 14, 2016. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Guangdong Transtek Medical Electronics Co., Ltd. has at least 10 other 510(k) clearances on record.