510(k) K213503

Wrist Blood Pressure Monitor, models AOJ-35A, AOJ-35B, AOJ-35C, AOJ-35D, AOJ-35E by Shenzhen AOJ Medical Technology Co., Ltd. — Product Code DXN

K213503 is an FDA 510(k) premarket notification submitted by Shenzhen AOJ Medical Technology Co., Ltd. for the device "Wrist Blood Pressure Monitor, models AOJ-35A, AOJ-35B, AOJ-35C, AOJ-35D, AOJ-35E". The FDA issued a decision of Substantially Equivalent on February 18, 2022. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Shenzhen AOJ Medical Technology Co., Ltd. has at least 10 other 510(k) clearances on record.